BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTCLIX LANCET DEVICE

    MDR report key: 1220084 · Received October 31, 2008

    Report

    Report Number
    1823260-2008-08094
    Event Type
    Malfunction
    Date Received
    October 31, 2008
    Date of Event
    October 29, 2008
    Report Date
    October 31, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER ALLEGED THE LANCET NEEDLE DID NOT RETRACT AFTER FIRING IN THE SOFTCLIX LANCET DEVICE. THE CUSTOMER REPORTED NO ACCIDENTAL STICKS. 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

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR "GLYPAZIDE" - 3-4 YEARS - 10 MG TWICE DAILY| ACTOS - 2 YEARS - 15 MG DAILY| "GLUCOPAGE" - 3-4 YEARS - "2.5 TABLETS" 2X DAILY