BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1811144 · Received August 13, 2010

    Report

    Report Number
    2183996-2010-01608
    Event Type
    Malfunction
    Date Received
    August 13, 2010
    Date of Event
    June 21, 2010
    Report Date
    July 21, 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
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, PATIENT REPORTED BOTH THE UP AND DOWN BUTTONS ON THE INFUSION DEVICE STOPPED RESPONDING TO PRESS APPROXIMATELY 1 MONTH AGO. PATIENT SWITCHED TO HIS BACKUP INFUSION DEVICE. PATIENT HAS USED HIS INFUSION DEVICE FOR 2 YEARS AND PROGRAMS AN AVERAGE OF 10 BOLUSES PER DAY. INFUSION DEVICE HAS NOT BEEN DROPPED OR EXPOSED TO WATER OR INSULIN INGRESS. BOTH UP AND DOWN BUTTONS POP UP AFTER BEING 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-CHEK SPIRIT INSULIN INFUSION PUMP LZG ROCHE INSULIN DELIVERY SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR INFUSION SET| INSULIN