BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® FASTCLIX

    MDR report key: 11695576 · Received April 20, 2021

    Report

    Report Number
    3011393376-2021-01276
    Event Type
    Injury
    Date Received
    April 20, 2021
    Date of Event
    April 5, 2021
    Report Date
    July 23, 2025
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    CASE WITH PATIENT IDENTIFIER (B)(6) IS RELATED TO CASE WITH PATIENT IDENTIFIER (B)(6). PRODUCT NO LONGER AVAILABLE FOR RETURN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO (B)(6)-YEAR-OLD GIRLS FOUND A LANCING DEVICE IN THEIR SCHOOLYARD AND BOTH PRICKED THEMSELVES WHILE PLAYING WITH THE DEVICE. THE LANCING DEVICE BELONGED TO ANOTHER STUDENT. ONE OF THE MOTHERS TOOK BOTH GIRLS TO THE EMERGENCY ROOM. SHE STATED THAT BOTH GIRLS WERE RECEIVING MEDICATION FOR (B)(6) EXPOSURE AND OTHER MEDICATION FOR OTHER TYPES OF EXPOSURE, WHICH COULD HAVE SEVERE SIDE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592886 ACCU-CHEK ® FASTCLIX LANCET DEVICE FMK ROCHE DIABETES CARE, INC. ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Female Required Intervention