BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTCLIX PLUS LANCET DEVICE

    MDR report key: 1220290 · Received November 3, 2008

    Report

    Report Number
    1823260-2008-08133
    Event Type
    Malfunction
    Date Received
    November 3, 2008
    Date of Event
    October 21, 2008
    Report Date
    November 3, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 BAT059

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR FAMOTIDINE 20 MG/DAY| HYDROCODONE APAP 7.5/500MG 4/ - 1 YEAR| METFORMIN 1700 MG/DAY - 2 YEARS| IBUPROPHEN| BUPROPION 100 MG/DAY| GLIPIZIDE 5 MG/DAY - 8 MONTHS| LIPITOR 10 MG/DAY| METOPROLOL 25 MG/DAY| GABAPENTIN 1800 MG/DAY - 1 YEAR