FDA Adverse Event Injury Summary report: N

INSULIN PUMP CONTROL DEVICE (PDM)

MDR report key: 16043560 · Received December 22, 2022

Report

Report Number
MW5113995
Event Type
Injury
Date Received
December 22, 2022
Date of Event
November 12, 2022
Manufacturer
INSULET CORPORATION
Product Code
QRX
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
TX, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

INSULIN DISPENSED UNDER THE AUTOMATION MODE OF INSULET'S OMNIPOD 5 INSULIN PUMP IS NOT ACCOUNTED IN THE INSULIN ON BOARD TALLY THAT IS PROVIDED BY THE INSULIN PUMP CONTROL DEVICE (PDM) WHICH IS ALSO AN INSULET MANUFACTURED MEDICAL DEVICE AND IS A SEPARATE DEVICE FROM THE OMNIPOD INSULIN PUMP POD. THE INSULIN ON BOARD TALLY IS RELIED UPON BY THE INSULIN PUMP OPERATOR TO DETERMINE APPROPRIATE INSULIN BOLUS DOSAGE WHEN A BOLUS IS NEEDED FOR MEALS OR HIGH GLUCOSE LEVEL CORRECTION. IN MY EPISODE, THE PUMP HAD DISPENSED NEARLY 3 UNITS OF INSULIN OVER THE COURSE OF AN HOUR ACROSS 5 MINUTE INCREMENTS. THIS WAS NOT REFLECTED IN THE INSULIN ON BOARD TALLY. SO UPON BEING WOKEN BY A HIGH GLUCOSE ALARM, I ORDERED THE PDM TO BOLUS A DOSAGE OF INSULIN RELYING ON THE INSULIN ON BOARD TALLY VERSUS THE CURRENT GLUCOSE STATUS. THE BOLUS PLUS THE EXISTING INSULIN FROM THE PUMPS AUTOMATION IN MY SYSTEM WAS TOO MUCH AND I WAS AWOKEN LATER IN THE EVENING WITH A LOW GLUCOSE ALARM FINDING THAT MY GLUCOSE WAS QUICKLY DROPPING BELOW 47.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
2050547 INSULIN PUMP CONTROL DEVICE (PDM) CONTINUOUS GLUCOSE MONITOR INFORMED INSULIN DOSE CALCULATOR QRX INSULET CORPORATION
2050548 OMNIPOD 5 ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QRX INSULET CORPORATION

Patients

Seq Age Sex Outcome Treatment
1 50 YR Male Life Threatening DEXCOM G6 CONSTANT GLUCOSE MONITOR| FIASP U100 ASPART INSULIN