BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2210190 · Received July 8, 2011

    Report

    Report Number
    2183996-2011-01951
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 23, 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
    MO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, PT REPORTED THAT HE EXPERIENCED HYPERGLYCEMIA IN THE 400 MG/DL RANGE DUE TO THE UP/DOWN BUTTONS ON THE INFUSION DEVICE NOT WORKING PROPERLY. NORMAL BLOOD GLUCOSE IS IN THE 200 MG/DL RANGE, AND PT BOLUSED TO TREAT HYPERGLYCEMIA. THIS FIRST OCCURRED AT THE BEGINNING OF (B)(6) 2011, AND PT SWITCHED TO HIS BACKUP INFUSION DEVICE. INFUSION DEVICE WAS NOT DROPPED OR EXPOSED TO WATER. PT HAS USED THIS INFUSION DEVICE FOR 4 YEARS AND BOLUSES 8-10 TIMES PER DAY. THE UP/DOWN BUTTONS DO NOT REMAIN FLAT AFTER THEY ARE PRESSED. PT WAS UNSURE WHICH BUTTON WAS DEFECTIVE, AND BOTH BUTTONS RESPONDED CORRECTLY DURING THE TROUBLESHOOTING CALL. INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVAL. PT 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 INSULIN| INSULIN INFUSION SET