BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTCLIX LANCET DEVICE

    MDR report key: 1181696 · Received September 30, 2008

    Report

    Report Number
    1823260-2008-07248
    Event Type
    Malfunction
    Date Received
    September 30, 2008
    Date of Event
    September 22, 2008
    Report Date
    September 30, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTCLIX LANCET DEVICE LANCET DEVICE-FMK FMK ROCHE DIAGNOSTICS 1WO610

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR HUMALOG SLIDING SCALE - 5 YEARS