BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1981897 · Received January 14, 2011

    Report

    Report Number
    2183996-2011-00014
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    December 28, 2010
    Report Date
    January 4, 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
    VA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, PATIENT REPORTED THE DOWN BUTTON ON THE INFUSION DEVICE WORKS INTERMITTENTLY. THIS WAS NOTICED 1 WEEK PRIOR TO REPORT WHEN SHE TRIED TO INITIATE THE QUICK BOLUS FEATURE BY USING THE DOWN BUTTON. PATIENT BOLUSES 6 TIMES A DAY, AND THE BUTTON DOES POP UP AFTER 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-CHEK SPIRIT INSULIN INFUSION PUMP LZG ROCHE INSULIN DELIVERY SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR INSULIN INFUSION SET| INSULIN