BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1821278 · Received August 26, 2010

    Report

    Report Number
    2183996-2010-01712
    Event Type
    Malfunction
    Date Received
    August 26, 2010
    Date of Event
    August 7, 2010
    Report Date
    August 9, 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
    NE, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, PATIENT REPORTED THE DOWN BUTTON ON HIS INFUSION DEVICE WAS NO LONGER RESPONDING TO PRESS. THIS WAS FIRST NOTICED ON (B)(6) 2010 WHEN ATTEMPTING TO BOLUS. PATIENT SWITCHED TO BACKUP INFUSION DEVICE. INFUSION DEVICE HAS BEEN IN USE FOR APPROXIMATELY 3 YEARS AND PATIENT BOLUSES 3-5 TIMES PER DAY. DOWN BUTTON POPS UP AFTER BEING PRESSED. INFUSION DEVICE HAS NOT BEEN DROPPED OR 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 56 YR INSULIN| INFUSION SET