BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLUCOSE SENSOR FREESTYLE LIBRE 3 PLUS

    MDR report key: 24292828 · Received February 9, 2026

    Report

    Report Number
    MW5183521
    Event Type
    Injury
    Date Received
    February 9, 2026
    Date of Event
    January 26, 2026
    Report Date
    February 2, 2026
    Manufacturer
    ABBOTT DIABETES CARE INC.
    Product Code
    QBJ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    REPORT: (B)(4): LLT CODES: 10069327: PRODUCT QUALITY ISSUE I NARRATIVE: SENSOR HAS NOT BEEN WORKING PROPERLY-"SIGNAL LOST, NOT READING" CHANGED 1/20, 1/24, 1/25, 1/26 AND AGAIN 1/30- CALLED COMPANY WHO ATTEMPTED TO TROUBLE SHOOT WITH NURSING, UNABLE TO RESOLVE. NURSING WERE TOLD TO CHANGE SENSOR AGAIN, STATING IT MAY HAVE JUST BEEN A BAD BATCH. LOT NUMBER AND UNIQUE DEVICE IDENTIFIERS MATCH RECALL, HOWEVER SERIAL NUMBERS DO NOT. LOT 1268143. PT CODE: 4582. DEVICE CODES: 2917, 1535,1420. REFERENCE REPORTS: MW5183518, MW5183519, MW5183520, MW5183522.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350194 GLUCOSE SENSOR FREESTYLE LIBRE 3 PLUS INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED QBJ ABBOTT DIABETES CARE INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male