BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTCLIX LANCET DEVICE

    MDR report key: 2911601 · Received March 2, 2007

    Report

    Report Number
    1823260-2007-01778
    Event Type
    Malfunction
    Date Received
    March 2, 2007
    Date of Event
    February 7, 2007
    Report Date
    March 2, 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

    Additional Manufacturer Narrative · 1

    THE SUSPECT PRODUCT IS THE SOFTCLIX LANCET.

    Description of Event or Problem · 1

    DURING COMPLAINT INVESTIGATION IT WAS DISCOVERED THE LANCET DOES NOT RETRACT. TECHNICAL SUPPORT REQUESTED THE RETURN OF THE SUSPECT PRODUCT AND REPLACEMENT PRODUCT WAS SHIPPED. THE SYSTEM IS THE SOFTCLIX, LOT NOT PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA