BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTCLIX PLUS LANCET DEVICE

    MDR report key: 1752483 · Received July 30, 2007

    Report

    Report Number
    1823260-2007-06651
    Event Type
    Malfunction
    Date Received
    July 30, 2007
    Date of Event
    July 17, 2007
    Report Date
    July 30, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER ALLEGED THE LANCET NEEDLE WILL NOT RETRACT AFTER FIRING IN THE SOFTCLIX PLUS LANCET DEVICE. CUSTOMER REPORTED 2 ACCIDENTAL STICKS WITH UNRETRACTED LANCETS. CUSTOMER SELF-TREATED WITH ANTIBIOTIC CREAM AND ADHESIVE BANDAGE. NO MEDICAL TREATMENT WAS SOUGHT. 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 PLUS LANCET DEVICE LANCET DEVICE FMK ROCHE DIAGNOSTICS BAT012

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR NOVOLOG - CONTINUOUS PUMP| FLOMAX - 4 MONTHS - 0.8 DAILY| DILTIAZEM ER - 4 YEARS - 240 MG DAILY| LIPITOR - 3 YEARS - 20 MG DAILY| QUINARETIC - 4 YEARS - 20-25 MG TWICE DAILY