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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 Use of Device Problem (1670)
Patient Problems Hypoglycemia (1912); Loss of consciousness (2418)
Event Date 12/21/2023
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 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 12/25/2023, a beta bionics clinical diabetes specialist (cds) reported during a follow-up call an ilet patient reported she was in the hospital due to a severe low blood glucose (bg) event.The patient reported on (b)(6) 2023 she "fell asleep" in the bathroom so her husband called 911.The patient does not remember falling asleep.The patient reported when the ems arrived her bg was at 29 mg/dl.It is unknown what treatment the patient received by the ems and at the hospital.The patient removed the ilet and is back on manual injections.On 12/26/2023, the cds followed-up with the patient.The patient has been discharged from the hospital and is doing well.The cds and the patient scheduled a re-training for on (b)(6) 2024.Ilet log data from on (b)(6) 2023, was reviewed by beta bionics.It was discovered that from 6:38pm - 8:39pm the patient announced 3 separate meal boluses of 3.1 units while her bg was in the 40's mg/dl or below.On (b)(6) 2024, the cds assisted the patient with restarting on the ilet.During the re-training the patient reported she did not disconnect the infusion set from herself when changing her insulin cartridge.As a result, the patient primed herself with insulin during the fill tubing process.The patient is unsure how much insulin went into her body.Consequently, this may have also contributed to the patient's severe hypoglycemic event on (b)(6) 2023.The cds reviewed with the patient all items on the training checklist with special emphasis on hypoglycemia and appropriate treatment.The patient is currently back on the ilet and doing well.
 
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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 Key18548135
MDR Text Key333314872
Report Number3019004087-2024-00011
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 01/19/2024
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 12/25/2023
Initial Date FDA Received01/19/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/30/2023
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient SexFemale
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