BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTCLIX LANCET DEVICE

    MDR report key: 1778924 · Received November 21, 2007

    Report

    Report Number
    1823260-2007-10133
    Event Type
    Malfunction
    Date Received
    November 21, 2007
    Date of Event
    August 14, 2007
    Report Date
    November 21, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 WI0748

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR METFORMIN 2550 MG/DAY