BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFT TOUCH II

    MDR report key: 1770555 · Received October 25, 2007

    Report

    Report Number
    1823260-2007-09194
    Event Type
    Malfunction
    Date Received
    October 25, 2007
    Date of Event
    October 9, 2007
    Report Date
    October 22, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    510K EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS SOFT TOUCH LANCET WILL NOT RETRACT AFTER FIRING. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT TO CUSTOMER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR ACTOS - 30 MG ONCE DAILY| HUMULIN N - TWICE DAILY| HUMALOG - SLIDING SCALE| HUMULIN N - SLIDING SCALE| HUMALOG - ONCE DAILY