BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2024074 · Received March 11, 2011

    Report

    Report Number
    2183996-2011-00516
    Event Type
    Malfunction
    Date Received
    March 11, 2011
    Date of Event
    December 22, 2010
    Report Date
    February 22, 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
    PR, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, HUSBAND REPORTED THE UP AND DOWN BUTTONS ON THE INFUSION DEVICE DO NOT FUNCTION AS INTENDED. THE UP AND DOWN BUTTONS DO RESPOND IF THEY ARE PRESSED MULTIPLE TIMES. PATIENT BOLUSES 3-4 TIMES PER DAY. 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 58 YR INSULIN| INSULIN INFUSION SET