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Device Lab 55

Glucometer

Glucometer in the BMEssentia 3D Device Lab

A three-electrode printed strip carrying a dry film of glucose oxidase over a large excess of potassium ferricyanide, in a laminated capillary chamber of declared volume, read by a handheld meter that steps the working electrode to a fixed potential and samples the current at a declared time. Glucose oxidase is a flavoprotein: each glucose reduces the flavin, and the flavin is reoxidised by whatever accepts electrons fastest. The strip supplies a large excess of mediator so that it usually wins, and the sample supplies dissolved oxygen, which is what the enzyme evolved to use.

Also called: Glucose Meter, Blood Glucose Meter. Arabic: جهاز قياس السكر. Device Lab 55 of 69 in BMEssentia Medical City, 2 configurations.

Overview: the configurations

Glucose oxidase strip, ferricyanide mediated

A three-electrode printed strip carrying a dry film of glucose oxidase over a large excess of potassium ferricyanide, in a laminated capillary chamber of declared volume, read by a handheld meter that steps the working electrode to a fixed potential and samples the current at a declared time. Glucose oxidase is a flavoprotein: each glucose reduces the flavin, and the flavin is reoxidised by whatever accepts electrons fastest. The strip supplies a large excess of mediator so that it usually wins, and the sample supplies dissolved oxygen, which is what the enzyme evolved to use.

PQQ glucose dehydrogenase strip, oxygen independent

The same printed strip, the same chamber, the same mediator loading, the same electrodes and the same meter, carrying a dry film of a pyrroloquinoline quinone dependent glucose dehydrogenase in place of the oxidase. The quinone cofactor is reoxidised by the mediator and by nothing else in the sample, so the chain from sugar to electrode has one branch fewer than the other configuration has.

How it works: the main parts

What each part does, from the Glucometer lessons in the 3D Device Lab.

Meter body, case and the shape of a thing carried in a pocket
A moulded handheld shell about eighty-five by forty-eight by sixteen millimetres, with a slot in one end, a dark window over most of one face, two or three buttons, a battery door on the back and a lanyard eye. It closes in one hand.
Strip port, its contacts and the wake switch
A slot in one end of the meter body about nine millimetres deep, with three sprung gold-plated fingers inside it and a moulded stop at the back so a strip can only go in one way and only go in so far. Push a strip in and the display lights without anybody touching a button.
Display, and the single number on it
A segment panel behind a window about thirty-four millimetres by twenty-four, showing a value to one decimal place with a unit beside it, and occasionally a countdown, a code or a battery symbol instead. On the bench it is drawn with the sample value printed beside the reported one, which no real meter does.
Coin cell, power management and the one fault the meter announces
A lithium coin cell twenty millimetres across and a little over three thick, behind a door on the back of the case, with a spring contact and a clip. It powers everything: the potentiostat, the front end, the digitiser, the panel and the clock that keeps the timestamps.
Potentiostat and the applied potential
One of four functional blocks on a small board inside the case, drawn here as a block rather than as a circuit. It has one job: hold the working electrode at four tenths of a volt with respect to the printed silver counter, from the instant the chamber is confirmed full until the reading is taken, whatever current that requires.
Transimpedance front end and its current ranges
The second block on the board. The current returning from the strip arrives here as a few microamps and leaves as a voltage the digitiser can work with.
Digitiser and the sampling of a decaying current
The third block. It turns the front end output into a number, once, at an instant the clock chooses.
Thermistor, and the difference between the meter and the reaction
A small bead component soldered to the board inside the case, nowhere near the chamber and separated from it by a moulded wall, the strip port and several millimetres of air. It is the only sensor in this instrument that measures a physical condition rather than a current, and it measures the wrong one.

Explore it in the Device Lab

Common faults and what to check

Most reported device problems (FDA MAUDE)

Device problemReports
Device Displays Incorrect Message103,420
Failure to Power Up84,632
Incorrect Or Inadequate Test Results39,745
High Test Results26,617
Incorrect, Inadequate or Imprecise Result or Readings24,389
Device Operates Differently Than Expected19,195

Raw counts of adverse event reports for this device type (FDA product code NBW, PZI), all years. Not adjusted for the number of units in use, so they show what gets reported, not failure rates. Report text is never copied.

Planned maintenance checks

From the BMEssentia procedure library: every 12 months, about 15 minutes, electrical class II.

Point-of-care testing is governed by the laboratory's POCT committee (ISO 15197 performance for meters).

CheckPass when
Meter and strip port
Inspect the strip port and the case; clean per manufacturer.
Clean; no damage.
Control results review
Review the control log and run both levels.
Within the printed ranges.

Test instruments: Control solutions (levels).

Standards engineers test against

ISO 15197: blood glucose meters (self-testing)

The performance standard for blood glucose monitoring systems.

Recent FDA recalls

RecallProduct and reason
Z-3128-2026
2026-09-11
Nova Biomedical Corporation: StatStrip Glucose Hospital Meter System. Model No: 63685. Glucose test system.
A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermittently retain a previously scanned barcode including patient identification (ID). Root cause: Software design.
Z-3129-2026
2026-09-11
Nova Biomedical Corporation: StatStrip Glucose Hospital Meter System. Model No: 66739. Glucose test system.
A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermittently retain a previously scanned barcode including patient identification (ID). Root cause: Software design.
Z-3130-2026
2026-09-11
Nova Biomedical Corporation: StatStrip Glucose and B- Ketone meter. Model No: 63683. Glucose test system.
A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermittently retain a previously scanned barcode including patient identification (ID). Root cause: Software design.
Z-3131-2026
2026-09-11
Nova Biomedical Corporation: StatStrip Glucose and B- Ketone meter. Model No: 63910. Glucose test system.
A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermittently retain a previously scanned barcode including patient identification (ID). Root cause: Software design.
Z-3132-2026
2026-09-11
Nova Biomedical Corporation: StatStrip Glucose and B- Ketone meter. Model No: 66429. Glucose test system.
A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermittently retain a previously scanned barcode including patient identification (ID). Root cause: Software design.

From the FDA recall database (openFDA), newest first, imported 2026-10-22. 143 recalls on record for this device type. Recall text is the FDA's public text; each recall links to the official record.

Learn it, see it in 3D, ask about it

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