FDA Adverse Event Injury Summary report: N

ILET BIONIC PANCREAS

MDR report key: 21798235 · Received April 8, 2025

Report

Report Number
MW5168715
Event Type
Injury
Date Received
April 8, 2025
Date of Event
September 17, 2023
Report Date
April 3, 2025
Manufacturer
BETA BIONICS, INC.
Product Code
QFG
UDI-DI
00850050080046
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
CO, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

SOON AFTER COMPLETING ALL REQUIRED TRAINING ONLINE AND WITH THE CERTIFIED PUMP TRAINER EMPLOYED AND ASSIGNED TO ME BY BETA BIONICS, INC., I STARTED USING THIS NEW ILET INSULIN PUMP, I EXPERIENCED A SERIES OF MAJOR INSULIN OVERDOSES WHICH WERE DELIVERED BY PUMP USING LIFE-THREATENING DANGEROUS AND FAULTY ALGORITHMS. AS AN EXPERIENCED INSULIN PUMP USER, I KNEW THESE EVENTS WERE NOT NORMAL, AND ACTUALLY NEARLY KILLED ME BY ADMINISTERING AT LEAST TWO, IF NOT MORE, NEAR FATAL OVERDOSES OF INSULIN, FOR WHICH I HAD NO CONTROL OVER, UNTIL APPROXIMATELY 8-10 HOURS LATER WHEN I JUST HAD TO REMOVE THE DEVICE FROM MY BODY ALTOGETHER. DURING THESE SUDDEN-ONSET OVERDOSES, I NEEDED TO HAVE ASSISTANCE KEEPINGME IN A SEMI-CONSCIOUS STATE SO I COULD CONSUME MASSIVE AMOUNTS OF GLUCOSE TABLETS, SEVERAL DOSES OF ODANSETRON (AN ANTI-EMETIC), HIGHLY CONCENTRATED FRUIT JUICE, AND TWO DOSES OF GLUCAGON (BAQSIMI). I SURELY WOULD HAVE DIED THAT DAY WITHOUT MY FAMILY MEMBER'S RAPID RESPONSE AND ASSISTANCE. EVEN AFTER BLOOD GLUCOSE WOULD BRIEFLY STABILIZE, I SUBSEQUENTLY RECEIVED MORE INSULIN BOLUS OVERDOSES. I FOLLOWED THE TRAINING BY BETA BIONICS EXACTLY AND PRECISELY TO THE LETTER AND STILL NEARLY DIED. THIS PUMP IS DANGEROUS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
492280 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS, INC. BB1002 LA00049. REVA 00850050080046

Patients

Seq Age Sex Outcome Treatment
1 4 YR Female Required Intervention| L DEXCOM CGM SENSORS.| INSULIN PUMP.| INSULIN.