BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTCLIX LANCET DEVICE

    MDR report key: 1020176 · Received March 26, 2008

    Report

    Report Number
    1823260-2008-02742
    Event Type
    Malfunction
    Date Received
    March 26, 2008
    Date of Event
    March 18, 2008
    Report Date
    March 26, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED THE LANCET NEEDLE FROM THE CUSTOMER'S SOFTCLIX DEVICE USED IN FINGER-STICK BLOOD GLUCOSE TESTING WOULD NOT RETRACT AFTER IT WAS USED AND PROTRUDED OUTSIDE THE END CAP. REPORTER STATED SHE ACCIDENTALLY STUCK HERSELF WITH THE USED NEEDLE OF KNOWN PRIOR USE, SO SHE APPLIED ALCOHOL AND A BAND-AID TO HER FINGER. NO OTHER ACTIONS REPORTED TAKEN OR TREATMENT WAS RECEIVED. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE AND REPLACEMENT PRODUCT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTCLIX LANCET DEVICE LANCET DEVICE - FMK FMK ROCHE DIAGNOSTICS BAP108

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK FUROSEMIDE| COUMADIN| DILTIAZEM| COZAAR