BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTCLIX PLUS LANCET DEVICE

    MDR report key: 2894467 · Received October 23, 2007

    Report

    Report Number
    1823260-2007-09228
    Event Type
    Malfunction
    Date Received
    October 23, 2007
    Date of Event
    October 1, 2007
    Report Date
    October 23, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    RETURNED LANCET DEVICE COULD NOT BE TESTED DUE TO A DEFECTIVE PRIMING MECHANISM. UNABLE TO DETERMINE IF LANCET RETRACTS PROPERLY.

    Description of Event or Problem · 1

    CUSTOMER REPORTS LANCET WAS PERIODICALLY PROTRUDING FROM THE END-CAP OF THE SOFTCLIX PLUS LANCET DEVICE. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR RETURN OF THE SUSPECT PRODUCT AND A REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTCLIX PLUS LANCET DEVICE LANCET DEVICE - FMK FMK ROCHE DIAGNOSTICS BAT002

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR GLUCOPHAGE 1000MG 2X/DAY - 7 YEARS| LIPITOR 10MG 2X/DAY - RECENTLY