BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1830571 · Received September 3, 2010

    Report

    Report Number
    2183996-2010-01834
    Event Type
    Malfunction
    Date Received
    September 3, 2010
    Date of Event
    August 27, 2010
    Report Date
    August 28, 2010
    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
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, PT REPORTED THE DOWN BUTTON ON THE INFUSION DEVICE WAS DEFECTIVE. THIS WAS FIRST NOTICED ON (B)(6) 2010 WHEN TRYING TO PROGRAM A TEMPORARY BASAL RATE. THE DOWN BUTTON POPS UP AFTER BEING PRESSED. PT DOES NOT KNOW HOW LONG SHE HAS USED THIS INFUSION DEVICE AND BOLUSES 3-5 TIMES PER DAY. INFUSION DEVICE WAS NOT DROPPED OR EXPOSED TO WATER OR INSULIN INGRESS. UP BUTTON CONTINUES TO FUNCTION AS INTENDED. 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| INSULIN INFUSION SET