BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1964554 · Received December 22, 2010

    Report

    Report Number
    2183996-2010-02682
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    July 1, 2010
    Report Date
    December 14, 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
    AL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, MOTHER REPORTED THE DOWN BUTTON ON THE INFUSION DEVICE DOES NOT FUNCTION PROPERLY. THIS FIRST OCCURRED IN (B)(6) 2010. PATIENT HAS USED THIS INFUSION DEVICE FOR 2-3 YEARS AND BOLUSES APPROX 4-5 TIMES PER DAY. THE DOWN BUTTON DOES NOT POP UP AFTER IT IS PRESSED AND IS "STUCK DOWN." INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVAL. 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 16 YR INSULIN INFUSION SET| INSULIN