BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1811547 · Received August 17, 2010

    Report

    Report Number
    2183996-2010-01621
    Event Type
    Malfunction
    Date Received
    August 17, 2010
    Date of Event
    July 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
    IA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, PATIENT REPORTED THE DOWN BUTTON ON THE INFUSION DEVICE DID NOT RESPOND WHEN TRYING TO PROGRAM A BOLUS. ALL OTHER BUTTONS ON INFUSION DEVICE WERE FUNCTIONING AS INTENDED. PATIENT BOLUSES 3-5 TIMES PER DAY AND HAS USED THIS INFUSION DEVICE SINCE (B)(6), 2006. THE INFUSION DEVICE HAS NOT BEEN DROPPED OR EXPOSED TO WATER OR INSULIN INGRESS. DOWN BUTTON POPS BACK UP AFTER IT IS PRESSED. PATIENT IS ABLE TO GET DOWN BUTTON TO RESPOND BY "WIGGLING IT." 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 44 YR INSULIN INFUSION SET| INSULIN