BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBRE 2 SENSOR FREESTYLE

    MDR report key: 13220229 · Received January 11, 2022

    Report

    Report Number
    2954323-2022-01078
    Event Type
    Malfunction
    Date Received
    January 11, 2022
    Date of Event
    December 20, 2021
    Report Date
    January 10, 2022
    Manufacturer
    ABBOTT DIABETES CARE INC
    Product Code
    QLG
    UDI-DI
    00357599800000
    PMA / PMN Number
    K193371
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SENSOR (B)(4) HAS BEEN RETURNED AND INVESTIGATED. THE SENSOR PLUG IS FULLY SEATED AND NO ISSUES WERE OBSERVED. EXTRACTED DATA FROM THE RETURNED SENSOR USING APPROVED SOFTWARE. THE SENSOR WAS FOUND TO BE IN SENSOR STATE 5 (INDICATING NORMAL TERMINATION). INSPECTED THE PLUG ASSEMBLY. CIG ATTEMPTED TO REPROGRAM THE RETURNED PATCH, HOWEVER AN ERROR OCCURRED DURING REPROGRAMMING. AN EXTENDED INVESTIGATION WAS PERFORMED. PQE (PRODUCT QUALITY ENGINEERING GROUP) PERFORMED A VISUAL INSPECTION ON THE RETURNED PRODUCT, NO PHYSICAL DAMAGE WAS OBSERVED. PQE WAS UNABLE TO EXTRACT DATA FROM THE RETURNED SENSOR. VISUAL INSPECTION PERFORMED ON THE SENSOR PCBA (PRINTED CIRCUIT BOARD ASSEMBLY) AND OBSERVED LIQUID CONTAMINATION. PQE CLEANED THE SENSOR PCBA AND ATTEMPTED TO EXTRACT DATE AND PERFORM LINEARITY TEST. DATA EXTRACTION AND LINEARITY TEST WERE UNSUCCESSFUL. (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED RECEIVING ERRONEOUS GLUCOSE RESULTS FROM AN ABBOTT DIABETES CARE DEVICE. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FELL INTO EITHER THE C, D, OR E ZONE. 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
    180204 LIBRE 2 SENSOR FREESTYLE FLASH GLUCOSE MONITORING SYSTEM QLG ABBOTT DIABETES CARE INC 71992-01 00357599800000

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown