BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1915612 · Received December 1, 2010

    Report

    Report Number
    2183996-2010-02528
    Event Type
    Injury
    Date Received
    December 1, 2010
    Date of Event
    October 3, 2010
    Report Date
    November 19, 2010
    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
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, PT REPORTED HE WAS HOSPITALIZED THAT DAY DUE TO DIABETIC KETOACIDOSIS. BLOOD GLUCOSE WAS 200 MG/DL BEFORE HE WENT TO THE HOSPITAL. BLOOD GLUCOSE WAS IN THE 300 MG/DL RANGE WHILE IN THE HOSPITAL. PT WAS ALSO HOSPITALIZED ON (B)(6) 2010 AND (B)(6) 2010 FOR THE SAME REASON. TARGET BLOOD GLUCOSE IS 100-200 MG/DL. PT BELIEVES THE INFUSION DEVICE WAS THE CAUSE OF HYPERGLYCEMIA. INFUSION DEVICE BATTERY WAS CHANGED 3 TIMES IN 3 DAYS DURING HYPERGLYCEMIC EVENTS. CORRECT TYPE OF BATTERY WAS USED IN INFUSION DEVICE. BATTERY COVER AND ADAPTER HAVE NEVER BEEN CHANGED. INFUSION NEEDLE AND INSULIN CARTRIDGE ARE CHANGED EVERY 3 DAYS AND TUBING EVERY 6 DAYS. INSULIN CARTRIDGES ARE NOT REUSED. INFUSION DEVICE BUTTONS WERE FUNCTIONING PROPERLY. THERE WERE NO AIR BUBBLES, BLOOD, OR LEAKS IN THE SYSTEM. TIME ON INFUSION DEVICE WAS WRONG AND WAS CORRECTED DURING CALL. INSULIN WAS NOT EXPIRED AND WAS WARMED TO ROOM TEMPERATURE. INFUSION DEVICE WAS NOT DROPPED OR EXPOSED TO INSULIN INGRESS. BOLUS HISTORY WAS CORRECT. NO LIFESTYLE CHANGES WERE REPORTED. FOLLOW-UP WAS COMPLETED ON (B)(6) 2010 WITH WIFE. PT WAS HOSPITALIZED AGAIN DUE TO HIGH AMMONIA LEVELS AND WAS DISCHARGED ON DAY OF FOLLOW-UP. PT WAS TAKEN OFF INFUSION DEVICE WHILE IN HOSPITAL. FOLLOW-UP WAS AGAIN COMPLETED ON (B)(6) 2010, AND INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVAL.

    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 68 YR Hospitalization| R INSULIN| INSULIN INFUSION SET