BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1973900 · Received January 20, 2011

    Report

    Report Number
    2183996-2011-00036
    Event Type
    Injury
    Date Received
    January 20, 2011
    Date of Event
    December 28, 2010
    Report Date
    January 3, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, PRIMARY CARE PHYSICIAN REPORTED PT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2010 AND DIAGNOSED WITH DIABETIC KETOACIDOSIS. PHYSICIAN REPORTED CONCERN WITH ACCURACY OF INSULIN DELIVERY THROUGH INFUSION DEVICE AND EXPLAINED PT DID NOT HAVE ISSUES WITH ELEVATED BLOOD GLUCOSE WHILE ON PREVIOUS INFUSION DEVICE. PHYSICIAN REPORTED "NOTHING HAS CHANGED SINCE GOING ON THE PUMP," AND PT IS VERY COMPLIANT. INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVALUATION. F/U WAS COMPLETED WITH PT ON (B)(6) 2011. PT REPORTED SHE WENT TO THE EMERGENCY ROOM WITH A VIRUS AND WAS DIAGNOSED WITH EARLY STAGES OF KETOACIDOSIS. SHE REC'D TREATMENT FOR THE VIRUS AND WAS PLACED ON AN INSULIN DRIP. BLOOD GLUCOSE WAS 321 MG/DL AT THE TIME. NORMAL BLOOD GLUCOSE IS 80-120 MG/DL. PT WAS KEPT IN THE INTENSIVE CARE UNIT FOR ONE NIGHT AND WAS THEN DISCHARGED. PT REC'D AND STARTED REPLACEMENT INFUSION DEVICE, AND BLOOD GLUCOSE RETURNED TO NORMAL RANGE.

    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 22 YR Hospitalization| R (DATE OF TX: (B)(6))| INSULIN INFUSION SET:| INSULIN (DATE OF TX: (B)(6))