MAUDE Adverse Event Report: BETA BIONICS INC. INSET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	FG000016-05
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	03/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the available information, this event is deemed to be a reportable malfunction.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.Fda registration number reporting site: 8021545.Manufacturing site: 3003442380.Request was performed for additional information including lot number; however, lot number was not provided.A complaint investigation was initiated under complaint investigation.Unfortunately, no specific lot number was identified, which limits the ability to trace or analyze a particular item.Investigation in progress (editable/can be removed).
Event or Problem Description
It was reported that the patient experienced hyperglycemia associated with a bent cannula.No further information available.

• Brand Name: INSET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BETA BIONICS INC.; 8 saint mary¿s street; suite 936; boston MA 02215
• Manufacturer (Section G): BETA BIONICS INC.; 8 saint mary¿s street; suite 936; boston MA 02215
• Manufacturer Contact: courtney smith ; aaholmvej 1 - 3; osted; lejre 4320 ; DA 4320 ; 6032470255
• MDR Report Key: 24784820
• Report Number: 3003442380-2026-89456
• Device Sequence Number: 9935582
• Product Code: FPA
• UDI-Device Identifier: 05705244026254
• UDI-Public: 05705244026254
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K032854
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/07/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: FG000016-05
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2026
• Initial Report FDA Received Date: 04/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Age: 20 YR
• Patient Sex: Male