BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1811549 · Received August 17, 2010

    Report

    Report Number
    2183996-2010-01618
    Event Type
    Malfunction
    Date Received
    August 17, 2010
    Date of Event
    July 21, 2010
    Report Date
    July 22, 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
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, PATIENT REPORTED THE DOWN BUTTON ON HIS INFUSION DEVICE WAS NOT FUNCTIONING PROPERLY. THIS WAS NOTICED ON (B)(6) 2010. CONFIRMED UP BUTTON WAS FUNCTIONING AS INTENDED, AND THE DOWN BUTTON DID NOT RESPOND. PATIENT HAS USED THIS INFUSION DEVICE FOR OVER 2 YEARS AND BOLUSES 4 TIMES PER DAY. DOWN BUTTON DOES NOT POP UP AFTER BEING PRESSED. PATIENT REPORTED INFUSION DEVICE HAS BEEN DROPPED A COUPLE OF TIMES. THIS OCCURRED APPROXIMATELY 6 MONTHS AGO. INFUSION DEVICE HAS NOT BEEN EXPOSED TO WATER OR INSULIN INGRESS. PRODUCT 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 50 YR INSULIN INFUSION SET| INSULIN