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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BETA BIONICS ILET BIONIC PANCREAS; INTEROPERABLE AUTOMATED GLYCEMIC CONTROLLER

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BETA BIONICS ILET BIONIC PANCREAS; INTEROPERABLE AUTOMATED GLYCEMIC CONTROLLER Back to Search Results
Model Number BB1001
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hypoglycemia (1912); Loss of consciousness (2418)
Event Date 12/26/2023
Event Type  Injury  
Manufacturer Narrative
No product was returned for evaluation.The ilet logs were reviewed by beta bionics failure investigation department.No product performance issues were identified.If the product is received at a later date, the complaint will be reopened and investigated accordingly.No anomalies were observed.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.
 
Event Description
On 12/28/2023, a beta bionics clinical diabetes specialist (cds) reported an ilet patient experienced a severe hypoglycemic event on (b)(6) 2023.Per the patient, she first experienced hyperglycemia on (b)(6) 2023 due to a bent infusion set cannula.The infusion set was changed, and insulin delivery resumed.The patient then went to bed.Then, sometime in the morning on (b)(6) 2023, the patient's blood glucose (bg) went low, and the patient lost consciousness.The patient's husband called ems and when they arrived on scene they took the ilet off the patient.The patient was transported to a hospital.The patient is unsure what her bg went down to.The patient is also unsure what ems administered but did mention "some sort of iv." the patient was released from the hospital on (b)(6) 2023.The patient is currently still off the ilet and is using backup insulin therapy.Ilet log data from on (b)(6) 2023 was reviewed by beta bionics.Leading up to the event, the patient's bg was decreasing from above 400mg/dl at 2:45am and reached 107mg/dl at 4:30am.Throughout this time, the ilet was continuously requesting basal deliveries of insulin every 5 minutes.At 4:30am, the ilet ceased basal delivery.The patient's bg continued to decrease until 6:45am where it began to increase.The patient had been on the ilet for over two months.The patient had recently factory reset her ilet on friday on (b)(6) 2023.Before the factory reset, the patient was experiencing glycemic variability.The patient was inconsistent with meal boluses and had been experiencing some hypoglycemia.The patient would often over treat her hypoglycemia.On (b)(6) 2023, the cds had spoken with the patient and raised her daytime bg target to usual, instructed the patient to announce usual size meal boluses, and reviewed the proper treatment of hypoglycemia.
 
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Brand Name
ILET BIONIC PANCREAS
Type of Device
INTEROPERABLE AUTOMATED GLYCEMIC CONTROLLER
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
MDR Report Key18549371
MDR Text Key333315284
Report Number3019004087-2024-00012
Device Sequence Number1
Product Code QJI
UDI-Device Identifier850050080015
UDI-Public(01)850050080015
Combination Product (y/n)N
PMA/PMN Number
K232224
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/21/2024
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
Device Operator Lay User/Patient
Device Model NumberBB1001
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/28/2023
Initial Date FDA Received01/22/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/14/2023
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
CONVATEC INSET (23", 6MM) INFUSION SET.
Patient Outcome(s) Hospitalization;
Patient SexFemale
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