BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROLET®

    MDR report key: 22372460 · Received July 1, 2025

    Report

    Report Number
    1810909-2025-00100
    Event Type
    Malfunction
    Date Received
    July 1, 2025
    Date of Event
    June 3, 2025
    Report Date
    August 13, 2025
    Manufacturer
    ASCENSIA DIABETES CARE US INC.
    Product Code
    QRL
    UDI-DI
    05016003657108
    PMA / PMN Number
    K220633
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION OF THE MICROLET LANCETS WAS PERFORMED AT THE SUPPLIER SITE, HTL. DURING THE INJECTION MOLDING PROCESS FOR LANCETS, RAW NEEDLES ARE MOUNTED IN A CASSETTE AND FED INTO THE MOLDING MACHINE. A ROBOTIC ARM TRANSFERS THESE RAW NEEDLES TO THE MOLD. OCCASIONALLY, A RAW NEEDLE MAY FALL FROM THE ROBOTIC ARM AND MIX WITH THE FINISHED PRODUCT. THE FINISHED PRODUCT IS THEN DIRECTED TO A SEPARATOR EQUIPPED WITH A VIBRATING DRUM CONTAINING HOLES/SLOTS DESIGNED TO SEPARATE RAW NEEDLES FROM MOLDED LANCETS. THE PROBABLE CAUSE OF RAW NEEDLES NOT BEING SEPARATED FROM THE FINISHED PRODUCT COULD BE PLASTIC PARTICLES, WHICH WERE DEPOSITED IN THE HOLES/SLOTS AND THUS PREVENTED PROPER OPERATION OF THE SEPARATOR. IN ORDER TO INCREASE THE EFFICIENCY OF SEPARATION OF NEEDLES, A GRATE HAS BEEN ADDED DURING THE PRODUCTION PHASE AND A CONTAINER WAS ALSO PLACED BENEATH THE CHUTE TO COLLECT SEPARATED RAW NEEDLES AND PREVENT THEIR REINTRODUCTION INTO THE FINISHED PRODUCT.

    Additional Manufacturer Narrative · 0

    NOT APPLICABLE CAPTURED IN SECTION A1 AS THERE WAS NO PATIENT INVOLVEMENT. THE MICROLET® LANCET WITH SKU # 6571 AND LOT # C09A4S 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 (HCP) FROM GERMANY CALLED TO REPORT THAT A LANCET WITHOUT PLASTIC MOLDING AND PROTECTIVE CAP WAS STUCK BEHIND THE ADHESIVE SECURITY SEAL OF THE MICROLET LANCET CARTON. THERE HAS BEEN NO ALLEGATION OF A NEEDLESTICK INJURY OR ANY OTHER ASSOCIATED ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. REPLACEMENT LANCETS WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1193771 MICROLET® BLOOD GLUCOSE LANCETS QRL ASCENSIA DIABETES CARE US INC. 03856893 C09A4S 05016003657108

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown