BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 1890049 · Received November 1, 2010

    Report

    Report Number
    2183996-2010-02190
    Event Type
    Injury
    Date Received
    November 1, 2010
    Date of Event
    October 2, 2010
    Report Date
    October 5, 2010
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS, INC.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT OCCURRED OUTSIDE THE UNITED STATES. INFORMATION CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFORMATION IS OBTAINED IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    BLOOD GLUCOSE WAS BETWEEN 75-394 MG/DL ON (B)(6) 2010. PATIENT ATE THROUGHOUT THE DAY AND DELIVERED INSULIN FOR FOOD AND BLOOD GLUCOSE THROUGH INFUSION DEVICE. BLOOD GLUCOSE WAS 382 MG/DL ON (B)(6) 2010 AT 10:00 A.M. PATIENT FELT SICK AND DELIVERED INSULIN THROUGH THE INFUSION DEVICE. PATIENT CHECKED THE INFUSION DEVICE AND SAW INSULIN IN THE CARTRIDGE COMPARTMENT. PATIENT CHANGED THE INSULIN CARTRIDGE AND INFUSION SET AND DRIED THE CARTRIDGE COMPARTMENT. BLOOD GLUCOSE LOWERED TO 97 MG/DL AT 2:30P.M. BLOOD GLUCOSE WAS 154 MG/DL AT 6:30 A.M. ON (B)(6) 2010. PATIENT ATE AND DELIVERED INSULIN THROUGH INFUSION DEVICE. BLOOD GLUCOSE ELEVATED TO 281 MG/DL AT 12:00PM. PATIENT CHECKED THE INFUSION DEVICE AND SAW INSULIN IN THE CARTRIDGE COMPARTMENT. PATIENT THEN DELIVERED ADDITIONAL INSULIN THROUGH INFUSION DEVICE. PATIENT DOES NOT REUSE CARTRIDGES AND CHANGES CARTRIDGE EVERY 6-7 DAYS. INFUSION HEADSET IS CHANGED EVERY 2 DAYS AND TUBING EVERY 6-7 DAYS. CORRECT TYPE OF BATTERY IS USED IN INFUSION DEVICE. INFUSION DEVICE WAS NOT EXPOSED TO WATER OR ELECTROMAGNETIC FIELDS. PATIENT DID NOT LOSE CONSCIOUSNESS. THE PATIENT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVALUATION. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE INSULIN DELIVERY SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention INSULIN INFUSION SET| INSULIN