BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTCLIX PLUS LANCET DEVICE

    MDR report key: 1761281 · Received July 20, 2007

    Report

    Report Number
    1823260-2007-06357
    Event Type
    Malfunction
    Date Received
    July 20, 2007
    Date of Event
    October 31, 2006
    Report Date
    July 20, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS THE LANCET DOES NOT RETRACT INTO THE SOFTCLIX PLUS LANCET DEVICE. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTCLIX PLUS LANCET DEVICE LANCET DEVICE - FMK FMK ROCHE DIAGNOSTICS BAS020

    Patients

    Seq Age Sex Outcome Treatment
    1 NA