BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROLET®

    MDR report key: 24968545 · Received April 23, 2026

    Report

    Report Number
    1810909-2026-00019
    Event Type
    Malfunction
    Date Received
    April 23, 2026
    Date of Event
    March 22, 2026
    Report Date
    April 23, 2026
    Manufacturer
    ASCENSIA DIABETES CARE US INC.
    Product Code
    QRL
    UDI-DI
    05016003654701
    PMA / PMN Number
    K220633
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS THERE WAS NO PATIENT INVOLVEMENT, NO INFORMATION WAS CAPTURED IN SECTION A1, A2, A3 AND A4. THE MICROLET® LANCET WITH SKU # 6547R AND LOT # F09E8S HAS 510K # OF K220633 AND UDI # (B)(4). THE DEVICE WAS DISTRIBUTED OUTSIDE THE US, THEREFORE, NO GUDID INFORMATION EXISTS.

    Description of Event or Problem · 0

    A HEALTH CARE PROFESSIONAL FROM UNITED KINGDOM REPORTED THAT THAT THEY RECEIVED A BOX OF MICROLET® LANCET, AND FOUND THAT ONE LANCET DID NOT HAVE PLASTIC MOLDING OR PLASTIC CAP. THERE HAS BEEN NO ALLEGATION OF A NEEDLESTICK INJURY OR ANY OTHER ASSOCIATED ADVERSE EVENT. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95890 MICROLET® BLOOD GLUCOSE LANCETS QRL ASCENSIA DIABETES CARE US INC. 6547R F09E8S 05016003654701

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown