BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1843790 · Received September 10, 2010

    Report

    Report Number
    2183996-2010-01897
    Event Type
    Malfunction
    Date Received
    September 10, 2010
    Date of Event
    August 19, 2010
    Report Date
    August 26, 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
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, PATIENT REPORTED THE DOWN BUTTON ON THE INFUSION DEVICE WAS DEFECTIVE. THIS WAS FIRST NOTICED ONE WEEK PRIOR WHEN TRYING TO PROGRAM A BOLUS. THE DOWN BUTTON POPS UP AFTER BEING PRESSED. PATIENT DOES NOT KNOW HOW LONG SHE HAS USED THIS INFUSION DEVICE AND BOLUSES 5-6 TIMES PER DAY. INFUSION DEVICE HAS BEEN DROPPED, BUT IT WAS NOT DAMAGED OR CRACKED AS A RESULT. INFUSION DEVICE WAS NOT EXPOSED TO WATER OR INSULIN INGRESS. 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| INSULIN INFUSION SET