BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2170883 · Received June 22, 2011

    Report

    Report Number
    2183996-2011-01841
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Date of Event
    March 8, 2011
    Report Date
    June 8, 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
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, PT REPORTED THE INFUSION DEVICE DOES NOT DELIVER INSULIN ACCURATELY DUE TO DEFECTIVE BUTTONS. PT HAS EXPERIENCED HYPOGLYCEMIA IN THE 20-50 MG/DL RANGE. BLOOD GLUCOSE WAS 62 MG/DL ON (B)(6) 2011 AFTER PT ATE BREAKFAST, AND BLOOD GLUCOSE WAS 193 MG/DL BEFORE BED THE PREVIOUS NIGHT. PT TREATS HYPOGLYCEMIA BY EATING. THE UP AND DOWN BUTTONS ON THE INFUSION DEVICE WORK INTERMITTENTLY. PT DELIVERED INSULIN VIA SYRINGE ON THE DAY OF THE REPORT. PT REPORTED HE IS ALSO RECOVERING FROM ANKLE SURGERY. INFUSION DEVICE WAS NOT DROPPED, CRACKED, OR EXPOSED TO WATER. PT NOTICED THE BUTTONS WERE DEFECTIVE SEVERAL MONTHS AGO WHEN BOLUSING. PT HAS USED THIS INFUSION DEVICE FOR 4 YEARS AND BOLUSES 2 TIMES PER DAY. THE BUTTONS POP UP AFTER BEING PRESSED. INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVALUATION. 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 70 YR INSULIN| INSULIN INFUSION SET