FDA Adverse Event Malfunction Summary report: N

FREESTYLE LIBRE 3

MDR report key: 21349243 · Received February 10, 2025

Report

Report Number: 2954323-2025-04956
Event Type: Malfunction
Date Received: February 10, 2025
Date of Event: January 30, 2025
Report Date: February 10, 2025
Manufacturer: ABBOTT DIABETES CARE LTD
Product Code: QBJ
UDI-DI: 30357599818006
PMA / PMN Number: K223435
Removal / Correction Number: QUALITY RECORD QR987974
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 0

ADC INVESTIGATED THIS ISSUE AND DETERMINED THAT THE FREESTYLE LIBRE 3 SENSOR ASSOCIATED WITH THIS COMPLAINT DID NOT MEET PRODUCT DESIGN SPECIFICATIONS AND MAY PRODUCE HIGH GLUCOSE READINGS WHICH ARE NOT CLINICALLY ACCEPTABLE. BASED ON THE RESULTS OF THIS INVESTIGATION, THIS COMPLAINT IS CONFIRMED. THIS ISSUE WAS ADDRESSED BY THE FIELD ACTION 1034-2024 (FDA RECALL 2954323-07/24/24-001-R). IF THE PRODUCT IS RETURNED, NO FURTHER INVESTIGATION ACTIONS ARE REQUIRED AS THIS ISSUE IS CONFIRMED TO ADC FA1034-2024. THE DEVICE MFG DATE IS UNKNOWN. THE DATE ENTERED IN SECTION H4 IS THE DATE ABBOTT DIABETES CARE BECAME AWARE OF THE EVENT. ALL PERTINENT INFORMATION AVAILABLE TO ADC HAS BEEN SUBMITTED.

Description of Event or Problem · 0

A CUSTOMER REPORTED RECEIVING HIGH GLUCOSE SENSOR READINGS FROM AN ABBOTT DIABETES CARE (ADC) DEVICE. THIS IS A KNOWN ISSUE FOR THE SERIAL NUMBER ASSOCIATED WITH THIS COMPLAINT, ADDRESSED BY THE FIELD ACTION 1034-2024 (FDA RECALL 2954323-07/24/24-001-R). THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
960171	FREESTYLE LIBRE 3	CONTINUOUS GLUCOSE MONITORING SYSTEM	QBJ	ABBOTT DIABETES CARE LTD	72081-01		30357599818006

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown