BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHECK SPIRIT

    MDR report key: 1982067 · Received January 14, 2011

    Report

    Report Number
    2183996-2011-00010
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    July 3, 2010
    Report Date
    January 3, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS, INC.
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    Z-1415-2009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, PATIENT REPORTED THE UP BUTTON ON THE INFUSION DEVICE WAS NOT FUNCTIONING PROPERLY. THIS WAS FIRST NOTICED 6 MONTHS PRIOR TO REPORT. PATIENT IS STILL ABLE TO USE THE INFUSION DEVICE TO BOLUS, BUT HE HAS TO PRESS HARD USING HIS FINGERNAIL. INFUSION DEVICE HAS BEEN IN USE FOR APPROXIMATELY 2 YEARS, AND PATIENT BOLUSES 2-3 TIMES PER DAY. THE UP BUTTON OCCASIONALLY GETS STUCK WHEN IT IS PRESSED. INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVALUATION. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHECK SPIRIT INSULIN INFUSION PUMP LZG ROCHE INSULIN DELIVERY SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR INSULIN INFUSION SET| INSULIN