BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTCLIX LANCET DEVICE

    MDR report key: 1770552 · Received October 25, 2007

    Report

    Report Number
    1823260-2007-09197
    Event Type
    Malfunction
    Date Received
    October 25, 2007
    Date of Event
    October 4, 2007
    Report Date
    October 22, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    510K EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    THE CALLER REPORTED THAT THE LANCET WOULD NOT RETRACT INTO THE ACCU-CHEK SOFTCLIX LANCET DEVICE. THE CALLER WAS ACCIDENTALLY STUCK BUT DID NOT REPORT THAT MEDICAL INTERVENTION WAS REQUIRED. NO ADVERSE EVENT REPORTED. THE ACCU-CHEK CUSTOMER CARE SERVICE CENTER SENT NEW DEVICE AND REQUESTED RETURN OF SUSPECT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTCLIX LANCET DEVICE LANCET DEVICE - FMK FMK ROCHE DIAGNOSTICS MINI

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR ERYTHROMYCIN - 2000 MG/DAY - 3 DAYS