BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROLET®

    MDR report key: 21768128 · Received April 3, 2025

    Report

    Report Number
    1810909-2025-00053
    Event Type
    Injury
    Date Received
    April 3, 2025
    Date of Event
    March 5, 2025
    Report Date
    April 22, 2025
    Manufacturer
    ASCENSIA DIABETES CARE US INC.
    Product Code
    QRL
    UDI-DI
    05016003654701
    PMA / PMN Number
    K220633
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE SAFETY DATA SHEET FOR THE PLASTIC USED IN THE MOLDING OF THE MICROLET® LANCETS CAP WAS REVIEWED. THE MATERIAL OF THE LANCET CAP DOES NOT CONTAIN A HAZARDOUS SUBSTANCE OR MIXTURE. THE USER IS ADVISED TO SEEK MEDICAL ASSISTANCE UPON SWALLOWING OF THE LANCET CAP.

    Additional Manufacturer Narrative · 0

    THE PATIENT/FAMILY (A1) WAS THE INITIAL REPORTER (E1), SO PERSONAL INFORMATION WAS NOT ENTERED. NO INFORMATION WAS CAPTURED IN SECTION A4 AS THE CUSTOMER'S WEIGHT WAS NOT PROVIDED. THE MICROLET® LANCETS WITH SKU # 6547R AND LOT # D09E3S HAS THE 510K# OF K220633 AND UDI#: (B)(4). THE DEVICE WAS DISTRIBUTED OUTSIDE US, THEREFORE, NO GUDID INFORMATION EXISTS.

    Description of Event or Problem · 0

    THE CUSTOMER FROM GERMANY REPORTED THAT HE ACCIDENTALLY SWALLOWED A MICROLET® LANCET ENDCAP INSTEAD OF A LIPID LOWERING TABLET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1736293 MICROLET® BLOOD GLUCOSE LANCETS QRL ASCENSIA DIABETES CARE US INC. 6547R D09E3S 05016003654701

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male