BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFT TOUCH II

    MDR report key: 1181586 · Received September 25, 2008

    Report

    Report Number
    1823260-2008-07181
    Event Type
    Malfunction
    Date Received
    September 25, 2008
    Date of Event
    September 10, 2008
    Report Date
    September 25, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS LANCET DOES NOT RETRACT INTO SOFT TOUCH DEVICE AFTER FIRING. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE PRODUCT, REPLACEMENT SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFT TOUCH II LANCET DEVICE - FMK FMK ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR AMARYL - 8 MG/DAY| LANTUS - 40 UNITS/DAY