BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1890120 · Received October 29, 2010

    Report

    Report Number
    2183996-2010-02182
    Event Type
    Injury
    Date Received
    October 29, 2010
    Date of Event
    July 1, 2010
    Report Date
    October 16, 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
    UT, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, PATIENT REPORTED HIS INFUSION DEVICE WAS NOT DELIVERING THE PROPER AMOUNT OF INSULIN. IN (B)(6), 2010, PATIENT SPENT 10 MINUTES IN AN ATTIC WHILE WEARING INFUSION DEVICE. TEMPERATURE WAS APPROXIMATELY 160 DEGREES. THE WEEK FOLLOWING, PATIENT EXPERIENCED HYPERGLYCEMIA OF 250-300 MG/DL. PATIENT CORRECTED HYPERGLYCEMIA BY DELIVERING A BOLUS THROUGH INFUSION DEVICE. THIS SUCCESSFULLY LOWERED BLOOD GLUCOSE TO NORMAL BLOOD GLUCOSE OF 120 MG/DL. PATIENT INCREASED BASAL RATES DURING DAYTIME AND EVENING HOURS. NO ERRORS WERE RECEIVED AND INFUSION DEVICE BUTTONS WERE FUNCTIONING AS INTENDED. INFUSION SET IS CHANGED EVERY 3-4 DAYS. ADAPTER WAS APPROXIMATELY 10 MONTHS OLD AND NO LEAKS WERE DETECTED IN THE SYSTEM. PATIENT WAS NOT SURE OF MANUFACTURER OR TYPE OF CURRENT BATTERY IN INFUSION DEVICE. INSULIN CARTRIDGES ARE REUSED 4-5 TIMES. PATIENT DOES NOT ALLOW INSULIN TO REACH ROOM TEMPERATURE AND FILLS 6-7 CARTRIDGES AT A TIME. TWO OF THREE TIMES SINCE (B)(6), 2010, THE INFUSION DEVICE HAS NOT PRIMED THE TUBING ON THE FIRST ATTEMPT. PATIENT DISCONNECTED INFUSION TUBING FROM HEADSET DURING TROUBLESHOOTING CALL AND BOLUSED 2 UNITS. NO INSULIN FLOWED FROM TUBING. INFUSION DEVICE WAS NOT DROPPED OR EXPOSED TO WATER OR INSULIN INGRESS. PATIENT SWITCHED TO BACKUP INFUSION DEVICE FOR PURPOSE OF TROUBLESHOOTING. FOLLOW-UP WAS COMPLETED. BLOOD GLUCOSE WAS "UNDER CONTROL" WHILE ON BACKUP INFUSION DEVICE. PRIMARY 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 64 YR Required Intervention INSULIN| INSULIN INFUSION SET