BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTCLIX PLUS LANCET DEVICE

    MDR report key: 1082541 · Received July 23, 2008

    Report

    Report Number
    1823260-2008-05717
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Date of Event
    July 19, 2008
    Report Date
    July 23, 2008
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS LANCET DID NOT RETRACT INTO SOFTCLIX PLUS DEVICE AFTER FIRING. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE PRODUCT, 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 CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR METFORMIN 1000MG/DAY| FEMARA 2.5 MG/DAY - 1 1/2 YEARS| COUMADIN/WARFARIN 5MG/DAY - 6 YEARS| LISINOPRIL 20MG/DAY - 6 YEARS| OXYBUTYNIN 5MG/DAY - OVER 1 YEAR| LANOXIN 0.25MG/DAY - 6 YEARS| SOTALOL 80MG/DAY - 6 YEARS