BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTCLIX LANCET DEVICE

    MDR report key: 1760916 · Received July 17, 2007

    Report

    Report Number
    1823260-2007-06200
    Event Type
    Malfunction
    Date Received
    July 17, 2007
    Date of Event
    July 1, 2007
    Report Date
    July 17, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    510K EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED THE NEEDLE THAT IS APART OF THE SOFTCLIX SYSTEM USED IN FINGER-STICK BLOOD GLUCOSE TESTING WOULD NOT RETRACT AFTER USE. REPORTER STATED, SHE DISCONTINUED THE USE OF THE LANCET AFTER IT WOULD NOT RETRACT AND NO OTHER ACTIONS WERE TAKEN AND NO TREATMENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE AND REPLACEMENT PRODUCT WAS SENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR GLUCOPHAGE - 7 YEARS - 1000MG TWICE DAILY| GLUCOTROL - 1 YR - 5MG TWICE DAILY