BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTCLIX LANCET DEVICE

    MDR report key: 1170815 · Received September 15, 2008

    Report

    Report Number
    1823260-2008-06901
    Event Type
    Malfunction
    Date Received
    September 15, 2008
    Date of Event
    August 26, 2008
    Report Date
    September 15, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    THE REPORTER STATES THAT THE LANCET DOES NOT RETRACT BACK INTO THE CAP OF THE ACCU-CHEK SOFTCLIX LANCET DEVICE AFTER FIRING. NO SYMPTOMS REPORTED. THE CUSTOMER WAS ACCIDENTALLY STUCK. THE CUSTOMER IS THE ONLY USER OF THE LANCET DEVICE, AND HAD USED IT SEVERAL TIMES PRIOR TO ACCIDENTAL STICK. NO ACTION TAKEN OR TREATMENT GIVEN BASED ON THE LANCET DEVICE ISSUE. NO MEDICAL INTERVENTION REQUIRED. NO ADVERSE EVENT REPORTED. NEW LANCET DEVICE WITH LANCETS SENT AND RETURN REQUESTED. THE REPORTER COULD NOT PROVIDE LANCET DEVICE LOT NUMBER.

    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 67 YR LANTUS| NOVOLOG| NEXIUM