BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2010170 · Received March 1, 2011

    Report

    Report Number
    2183996-2011-00351
    Event Type
    Malfunction
    Date Received
    March 1, 2011
    Date of Event
    February 8, 2011
    Report Date
    February 15, 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 Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, PT REPORTED THE DOWN BUTTON THE INFUSION DEVICE WAS NOT FUNCTIONING PROPERLY. THIS WAS NOTICED WITHIN THE LAST WEEK WHEN PT ATTEMPTED TO PROGRAM A BOLUS, AND THE INFUSION DEVICE WOULD NOT RESPOND. PT HAS USED THIS INFUSION DEVICE SINCE 2007, AND SHE TYPICALLY BOLUSES 5 TIMES PER DAY. THE DOWN BUTTON POPS UP AFTER IT IS PRESSED. INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVAL. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT 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-CHEK SPIRIT INSULIN INFUSION PUMP LZG ROCHE INSULIN DELIVERY SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR INSULIN INFUSION SET| INSULIN