BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2253051 · Received August 31, 2011

    Report

    Report Number
    2183996-2011-02370
    Event Type
    Malfunction
    Date Received
    August 31, 2011
    Date of Event
    June 23, 2011
    Report Date
    August 23, 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 Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, PATIENT REPORTED THE DOWN BUTTON ON THE INFUSION DEVICE IS DEFECTIVE. THIS WAS FIRST NOTICED 2 MONTHS AGO WHEN SHE TRIED TO BOLUS. THE DOWN BUTTON POPS UP AFTER IT IS PRESSED. PATIENT HAS USED THIS INFUSION DEVICE FOR 4 YEARS AND BOLUSES 3-4 TIMES PER DAY. THE UP BUTTON RESPONDED AS INTENDED DURING THE TROUBLESHOOTING CALL, BUT THE DOWN BUTTON DID NOT RESPOND. INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVALUATION. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. 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 61 YR INSULIN| INSULIN INFUSION SET