BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LIBRE 2

    MDR report key: 11041097 · Received December 18, 2020

    Report

    Report Number
    2954323-2020-14031
    Event Type
    Injury
    Date Received
    December 18, 2020
    Date of Event
    December 6, 2020
    Report Date
    December 18, 2020
    Manufacturer
    ABBOTT DIABETES CARE INC
    Product Code
    QLG
    PMA / PMN Number
    K193371
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    ABBOT DIABETES CARE PRODUCT QUALITY ENGINEERING (PQE) INVESTIGATED THE ALARM-3 (MISSING HIGH OR LOW GLUCOSE ) COMPLAINT. THE SERIAL NUMBER OF THE FREESTYLE LIBRE 2 SENSOR ASSOCIATED WITH THIS COMPLAINT IS UNKNOWN. DURING INVESTIGATION OF THE TRACK AND TREND REVIEW RELATED TO ALARM-3 CASES IN (B)(6) 2020 THIS FAILURE MODE WAS IDENTIFIED AND IS A KNOWN MANUFACTURING ISSUE THAT IMPACTS LIBRE 2 SENSORS MANUFACTURED AT FLEX BUFFALO GROVE (FBG). AS THE SERIAL NUMBER OF THE SENSOR ASSOCIATED WITH THIS COMPLAINT IS UNKNOWN, PQE IS UNABLE TO DETERMINE IF THE SENSOR IS IMPACTED BY THIS MANUFACTURING ISSUE. OUTSIDE OF THE KNOWN MANUFACTURING ISSUE, THE AVAILABLE TRIPPED TREND REPORTS FOR LIBRE 2 SENSOR AND ALARM-3 HAVE BEEN REVIEWED. THE REVIEW DID NOT IDENTIFY ANY ADDITIONAL TRENDS THAT WOULD INDICATE A PRODUCT RELATED ISSUE RELATED TO THIS COMPLAINT. IF THE PRODUCT IS RETURNED, THE CASE WILL BE RE-OPENED, AND A PHYSICAL INVESTIGATION WILL BE PERFORMED. THE DEVICE MFG DATE IS UNKNOWN. THE DATE ENTERED IS THE DATE ABBOTT DIABETES CARE BECAME AWARE OF THE EVENT. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED MISSING THE LOW GLUCOSE ALARM WHILE WEARING THE ADC FREESTYLE LIBRE 2 SENSOR. ON (B)(6) 2020, AS A RESULT, THE CUSTOMER EXPERIENCED COLD SWEATS AND LOST CONSCIOUSNESS. THE CUSTOMER WAS TREATED WITH AN INJECTION OF GLUCAGON BY THE CUSTOMER'S PARTNER. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1506849 FREESTYLE LIBRE 2 FLASH GLUCOSE MONITORING SYSTEM QLG ABBOTT DIABETES CARE INC 71992-01

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention