MAUDE Adverse Event Report: BETA BIONICS, INC. ILET BIONIC PANCREAS; ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP

Model Number	BB1002
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	09/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
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 keeping me 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.

• Brand Name: ILET BIONIC PANCREAS
• Common Device Name: ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP
• Manufacturer (Section D): BETA BIONICS, INC.
• MDR Report Key: 21798235
• Report Number: MW5168715
• Device Sequence Number: 12614576
• Product Code: QFG
• UDI-Device Identifier: 00850050080046
• UDI-Public: (01)00850050080046
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 04/03/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: BB1002
• Device Catalogue Number: XPYBMD380
• Device Lot Number: LA00049. REVA
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/08/2025
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DEXCOM CGM SENSORS.; INSULIN PUMP.; INSULIN.
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Age: 4 YR
• Patient Sex: Female
• Patient Weight: 54 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White