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Device Lab 27

Insulin Pump

Insulin Pump in the BMEssentia 3D Device Lab

A moulded case the size of a pager, worn on a waistband, containing a cell, a controller, a gearbox-and-lead-screw drive and a 3 mL reservoir barrel whose plunger the screw advances. A window in the side shows the barrel and the plunger. 60 m long leaves the bottom of the case and ends at a cannula under a dressing.

Also called: INSULIN PUMP. Arabic: مضخة الأنسولين. Device Lab 27 of 69 in BMEssentia Medical City, 2 configurations.

Overview: the configurations

Tethered syringe-driver pump with a compliant infusion set

A moulded case the size of a pager, worn on a waistband, containing a cell, a controller, a gearbox-and-lead-screw drive and a 3 mL reservoir barrel whose plunger the screw advances. A window in the side shows the barrel and the plunger. 60 m long leaves the bottom of the case and ends at a cannula under a dressing.

On-body patch pump with a rigid metering chamber and no set

A smooth lozenge adhered directly to the skin, containing a 2 mL reservoir, a cell, a controller and a rigid metering chamber of 1 mm bore swept 50 micrometres at a time between two mechanically seated check valves. There is no set and nothing leaves the pod: 40 mm of soft silicone link inside the shell carries the fluid from the outlet valve to the cannula. Delivery is a count of completed strokes, and that count is also how occlusion is detected.

How it works: the main parts

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

Reservoir barrel and the fluid it holds
A transparent barrel holding three millilitres, nine and a half millimetres across the bore, visible through a window in the side of the case with a plunger part way down it. On the other configuration it is a collapsing pouch inside a sealed pod instead, holding two millilitres, and nothing about it can be seen at all.
The moving seal between the mechanism and the fluid
A ribbed elastomer plunger four millimetres thick running in the barrel, with two sealing ribs and a short steel rod at its back. On the other configuration a single O-ring on a piston one millimetre across.
Outlet port, septum and the connection to the line
A short moulded boss at the bottom of the case with a pierced rubber septum in it and, on the tethered configuration, a tapered fitting below that. It is three millimetres of plastic, and it is the last place in the whole system where anything about the fluid is known.
The compliance chain, which is the whole device and is not a part
Not a component at all. It is the total springiness of everything between the metering element and the outlet, drawn on the schematic stand as four sections at twenty-two times life size with a bar under each showing its share.
Trapped gas, and the compliance it multiplies
A bubble. One microlitre of it is one point two four millimetres across; ten microlitres is two point six seven.
Soft cannula, dressing and the schematic interface
A dressing on the outside of the clothing, a small moulded hub and, on the schematic stand and nowhere else, a section of the cannula itself at twenty-two times life size beside a labelled tissue section. No puncture is depicted anywhere in this model.
The actuator that turns electricity into displacement
A stepper motor five and a half millimetres in radius and fourteen long, with two leads, on the tethered configuration. On the patch, a shape-memory alloy wire a third of a millimetre thick, a lever on a pivot and a return spring.
Position feedback, and the only delivery figure the device has
An optical disc with twelve slots turning with the motor shaft, and a slotted optical switch reading it. On the patch configuration, a contact that closes when the piston reaches the end of its stroke.

Explore it in the Device Lab

Common faults and what to check

Most reported device problems (FDA MAUDE)

Device problemReports
Device Displays Incorrect Message250,779
Break105,456
Patient Device Interaction Problem70,661
Device Operates Differently Than Expected65,647
No Display/Image61,210
Mechanical Problem52,552

Raw counts of adverse event reports for this device type (FDA product code LZG, OYC), 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 30 minutes, electrical class II, applied part type BF.

Patient-owned pumps are maintained by the manufacturer. Hospital checks cover the pumps the hospital holds and the in-patient policy.

CheckPass when
Case, buttons and reservoir bay
Inspect for cracks, water ingress and a secure battery cap.
No cracks; cap secure.
Delivery accuracy
Measure delivery at a basal rate with the analyser over the manufacturer's test period.
Within the manufacturer's accuracy.
Occlusion and clock
Block the line and confirm the occlusion alarm; check the clock.
Alarm per manufacturer; clock correct.

Test instruments: Infusion device analyser (micro-flow).

Recent FDA recalls

RecallProduct and reason
Z-2604-2026
2026-06-30
Insulet Corporation: Omnipod DASH Pod. Includes the below Model/REF Numbers:
External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being delivered to the user regardless of basal or bolus delivery. Root cause: Process design.
Z-2605-2026
2026-06-30
Insulet Corporation: Omnipod (Eros) Pod. Includes the below Model/REF Numbers:
External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being delivered to the user regardless of basal or bolus delivery. Root cause: Process design.
Z-1748-2026
2026-04-02
Medtronic MiniMed, Inc.: Paradigm Insulin Pump (MMT-712, MMT-715)
All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the. Root cause: Device Design.
Z-1743-2026
2026-04-02
Medtronic MiniMed, Inc.: MiniMed 640G Insulin Pump (MMT-1711, MMT-1712, MMT-1751, MMT-1752)
All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the. Root cause: Device Design.
Z-1745-2026
2026-04-02
Medtronic MiniMed, Inc.: MiniMed 720G Insulin Pump (MMT-1809, MMT-1810, MMT-1859, MMT-1860, MMT-1867)
All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the. Root cause: Device Design.

From the FDA recall database (openFDA), newest first, imported 2026-10-22. 160 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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