BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2170893 · Received June 22, 2011

    Report

    Report Number
    2183996-2011-01843
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Date of Event
    May 1, 2009
    Report Date
    June 7, 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 Location
    IN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, PATIENT REPORTED THAT THE UP BUTTON ON THE INFUSION DEVICE DOES NOT FUNCTION CORRECTLY. THIS WAS FIRST NOTICED IN (B)(6) 2009, AND PATIENT STOPPED USING THE INFUSION DEVICE AND SWITCHED TO INJECTION THERAPY. PATIENT DOES NOT REMEMBER IF THE BUTTONS POP UP AFTER BEING PRESSED AND REPORTED THE DOWN BUTTON MIGHT BE DEFECTIVE AS WELL. PATIENT BOLUSED 2-3 TIMES PER DAY AND STARTED USING THIS INFUSION DEVICE IN (B)(6) 2007. INFUSION DEVICE WAS NOT DROPPED. INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVALUATION. NO PHYSIOLOGICAL EFFECTS WERE REPORTED IN RELATION TO THIS EVENT. 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 47 YR INSULIN INFUSION SET| INSULIN