BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1991519 · Received January 28, 2011

    Report

    Report Number
    2183996-2011-00075
    Event Type
    Malfunction
    Date Received
    January 28, 2011
    Date of Event
    January 14, 2011
    Report Date
    January 18, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, PATIENT REPORTED HER INFUSION DEVICE WAS NOT DELIVERING ENOUGH INSULIN. BLOOD GLUCOSE HAD ELEVATED TO THE 200-400 MG/DL RANGE BEGINNING ON FRIDAY, (B)(6) 2011. PATIENT SWITCHED TO HER BACKUP INFUSION DEVICE ON (B)(6) 2011, AND BLOOD GLUCOSE DECREASED. NORMAL BLOOD GLUCOSE IS 169-170 MG/DL. NO ERROR MESSAGES WERE RECEIVED ON THE INFUSION DEVICE. INSULIN CARTRIDGE AND INFUSION SET ARE CHANGED EVERY 3 DAYS. ADAPTER WAS APPROXIMATELY 2 YEARS OLD. PATIENT WAS ADVISED ON MANUFACTURER RECOMMENDATIONS. THERE WERE NO AIR BUBBLES, BLOOD, OR LEAKS OF INSULIN IN THE SYSTEM. PATIENT DID NOT FORGET TO BOLUS, AND THERE WERE NO CHANGES IN HER LIFESTYLE. INFUSION DEVICE WAS NOT DROPPED, CRACKED, OR EXPOSED TO WATER OR OTHER LIQUID. INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVALUATION. 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 52 YR INSULIN INFUSION SET| INSULIN