BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFT TOUCH II

    MDR report key: 1080537 · Received July 22, 2008

    Report

    Report Number
    1823260-2008-05663
    Event Type
    Malfunction
    Date Received
    July 22, 2008
    Date of Event
    July 18, 2008
    Report Date
    July 22, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    THE REPORTER STATES THAT THE LANCET DOES NOT RETRACT BACK INTO THE CAP OF THE ACCU-CHEK SOFT TOUCH LANCET DEVICE AFTER FIRING. HE STATES THAT "THE LANCET REMAINS IN FINGER BUT DOES NOT BREAK OFF UNTIL HE MOVES FINGER AWAY". THE REPORTER ALSO STATES THAT THE SPRING IS WEAK. NO ACTION TAKEN OR TREATMENT GIVEN BASED ON THE LANCET DEVICE ISSUE. NO ACCIDENTAL STICK OR ADVERSE EVENT REPORTED. NEW LANCET DEVICE WITH LANCETS WAS SENT AND RETURN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFT TOUCH II LANCET DEVICE-FMK FMK ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ORAL MEDICATION