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

Model Number	BB1001
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Hypoglycemia (1912); Coma (2417)
Date of Event	11/27/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At the time of this report the ilet evaluation is still in progress.A follow-up report will be submitted when investigation is completed.
Event or Problem Description
On 12/3/24 a beta bionics clinical diabetes specialist (cds) was made aware that an ilet user experienced a low blood glucose (bg) event resulting in hospitalization.The event occurred on 11/27/24.The cds was notified by a dexcom representative that on 11/27/24 the user experienced a severe hypoglycemic event leading to hospitalization and is currently in a coma.The incident occurred while the user was asleep in the morning.Their spouse, who was out shopping, found them unresponsive upon returning home and contacted paramedics.Emergency medical personnel arrived around 3:00 pm, noting a blood glucose (bg) level of 31 mg/dl, and administered glucagon before transporting the user to the hospital.The user had a history of prolonged low bg events, attributed partly to delays in treating lows and alcohol consumption, as discussed during a zoom follow-up with a cds on 11/14/24.Despite education provided to both the user and their spouse on treating lows and addressing concerns, the event occurred shortly after.The cds had also shared a 14-day ilet report and concerns with the user's healthcare provider's office on 11/15/24.
Additional Manufacturer Narrative
No product was returned for evaluation.The ilet logs were reviewed by beta bionics failure investigation department.Data for the described event date of 2024-11-27 was unable to be reviewed as the currently available logs at the time of this report end on 2024-11-14 at 4:51am.No product performance issues can be identified.The device history record (dhr) review was completed, and this device passed all manufacturing release criteria for distribution.There were no issues identified that would have impacted this event.Without device data from the reported event date, the performance of the device cannot be evaluated, and the cause of the event cannot be determined.If further data is obtained, this case will be reopened for further investigation.

• Brand Name: ILET BIONIC PANCREAS
• Common Device Name: ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP
• Manufacturer (Section D): BETA BIONICS; 11 hughes; irvine CA 92618
• Manufacturer (Section G): BETA BIONICS; 11 hughes; irvine CA 92618
• Manufacturer Contact: joe conkey ; 11 hughes; irvine, CA 92618 ; 9494277785
• MDR Report Key: 21044794
• Report Number: 3019004087-2024-00729
• Device Sequence Number: 16991899
• Product Code: QFG
• UDI-Device Identifier: 850050080015
• UDI-Public: (01)850050080015
• Combination Product (Y/N): N
• PMA/510(K) Number: K231485
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: BB1001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/30/2024
• Supplement Report FDA Received Date: 04/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/19/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DEXCOM G7 CONTINUOUS GLUCOSE MONITOR
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 75 YR
• Patient Sex: Male