BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTCLIX LANCET DEVICE

    MDR report key: 1771993 · Received September 18, 2007

    Report

    Report Number
    1823260-2007-08171
    Event Type
    Malfunction
    Date Received
    September 18, 2007
    Date of Event
    September 2, 2007
    Report Date
    September 18, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED THE LANCET NEEDLE THAT IS A PART OF THE SOFTCLIX DEVICE LANCING SYSTEM USED IN FINGER-STICK BLOOD GLUCOSE TESTING WOULD NOT RETRACT AFTER IT WAS USED. REPORTER STATED PRIOR TO USING THE SYSTEM, THE LANCET NEEDLE WOULD NOT FIT PROPERLY INTO THE CARRIER AND APPEARED TO BE LOOSE. NO ACTIONS WERE REPORTEDLY TAKEN OR TREATMENT RECEIVED. 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 WIP819

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR ACTOPLUS - 2MOS, 15MG-500MG/TWICE DAILY| GLYNASE - 2YRS, 6M/TWICE DAILY