BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHECK SPIRIT

    MDR report key: 1811545 · Received August 17, 2010

    Report

    Report Number
    2183996-2010-01619
    Event Type
    Malfunction
    Date Received
    August 17, 2010
    Date of Event
    May 22, 2010
    Report Date
    July 22, 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
    MD, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, PATIENT REPORTED THE UP BUTTON ON THE INFUSION DEVICE STARTED TO WORK INTERMITTENTLY 2 MONTHS AGO. THE UP BUTTON HAS NOW STOPPED RESPONDING COMPLETELY. PATIENT SWITCHED TO BACKUP INFUSION DEVICE. PATIENT HAS USED THIS INFUSION DEVICE SINCE 2007 AND BOLUSES 6-8 TIMES PER DAY. INFUSION DEVICE HAS NOT BEEN DROPPED OR EXPOSED TO WATER OR INSULIN INGRESS. THE UP BUTTON DOES NOT REMAIN FLAT AFTER IT IS PRESSED. 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-CHECK SPIRIT INSULIN INFUSION PUMP LZG ROCHE INSULIN DELIVERY SYSTEMS INC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR INSULIN| INSULIN INFUSION SET