BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTCLIX PLUS LANCET DEVICE

    MDR report key: 1781059 · Received July 25, 2007

    Report

    Report Number
    1823260-2007-06490
    Event Type
    Malfunction
    Date Received
    July 25, 2007
    Date of Event
    July 4, 2007
    Report Date
    July 25, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS THAT LANCET WILL NOT RETRACT AFTER FIRING 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 BAS009

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR CELEXA - 20MG ONCE A DAY - 5 YEARS| DARVOCET - 650MG AS NEEDED - 5 YEARS| FERROUS GLUCONATE - 225MG ONCE - 5 YEARS| CINNAMON CAPSULE - 500MG TWICE - 1 YEAR| TEMAZEPAM - 30MG ONCE A DAY - 15 YEARS| METFORMIN - 500MG TWICE A DAY - 3 YEARS| LASIX - 40MG ONCE A DAY - 4 YEARS| MULTIVITAMIN - ONCE A DAY - 10 YEARS| LORATADINE - 10MG ONCE A DAY - 5 YEARS