MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRE 2; FLASH GLUCOSE MONITORING SYSTEM

Model Number 71992-01

Device Problem Material Twisted/Bent (2981)

Patient Problems Hypoglycemia (1912); Loss of consciousness (2418)

Event Date 04/14/2024

Event Type  Injury  

Event Description

A bent inserter needle was reported with the abbott diabetes care (adc) device, and the customer was unable to apply the device and monitor glucose levels.A reading of 43 mg/dl was obtained from an unspecified device and it further reported that the customer experienced a loss of consciousness.The customer had contact with a healthcare professional who diagnosed the customer with hypoglycemia and provided "ab" by for treatment.There was no report of death or permanent impairment associated with this event.

Manufacturer Narrative

(b)(6) has been returned and investigated.Visual inspection has been performed on sensor and no issues were observed.The sensor plug was seated in mount properly.Data was successfully extracted from the returned sensor using approved software.Removed the sensor plug and inspected the plug assembly, no failure mode observed.Additional visual inspection on the applicator has been completed, and no issues were observed.Applicator had fired correctly and pried open to inspect the sharp; and no issues observed with the sharp.Unable to further investigate due to sensor pack not returned.Therefore, this issue is no product returned.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Dhrs (device history review) for the freestyle libre sensor and freestyle libre sensor kit were reviewed and the dhrs showed the freestyle libre sensor and freestyle libre sensor kit passed all tests prior to release.All pertinent information available to abbott diabetes care has been submitted.

• Brand Name: FREESTYLE LIBRE 2
• Type of Device: FLASH GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE INC; 1360 south loop road; alameda CA 94502 7001
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda, CA 94502-7001 ; 5107495297
• MDR Report Key: 19191009
• MDR Text Key: 341139009
• Report Number: 2954323-2024-14437
• Device Sequence Number: 1
• Product Code: QLG
• UDI-Device Identifier: 00357599800000
• UDI-Public: (01)00357599800000(17)2024-08-31(10)KTP008053(91)71992-01-0006
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193371
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 71992-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2024
• Date Manufacturer Received: 04/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/09/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female