BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2233984 · Received August 31, 2011

    Report

    Report Number
    2183996-2011-02368
    Event Type
    Injury
    Date Received
    August 31, 2011
    Date of Event
    August 13, 2011
    Report Date
    August 24, 2011
    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

    PATIENT REPORTED BLOOD GLUCOSE ELEVATED ABOVE 500 MG/DL ON (B)(6) 2011 AND SHE EXPERIENCED DIABETIC KETOACIDOSIS. SHE DELIVERED INSULIN THROUGH THE INFUSION DEVICE ON (B)(6) 2011 AT 6:00-7:00 P.M., BUT THIS WAS NOT SUCCESSFUL IN LOWERING BLOOD GLUCOSE. PATIENT FELT VERY SICK AND WAS NAUSEOUS AND THREW UP. SHE CALLED AN AMBULANCE AND HER EMERGENCY DOCTOR ON (B)(6) 2011 AT 2:00 A.M. THE AMBULANCE TRANSPORTED HER TO THE HOSPITAL, AND BLOOD GLUCOSE LEVEL WAS 740 MG/DL. PATIENT WAS UNCONSCIOUS FOR 2-3 MINUTES. THE DOCTOR AND DIABETES COUNSELOR NOTICED A LOT OF AIR BUBBLES IN THE INSULIN CARTRIDGE AND INFUSION TUBE. FOLLOW-UP WAS COMPLETED WITH PATIENT ON (B)(6) 2011 AND AGAIN ON (B)(6) 2011. PATIENT FILLS THE CARTRIDGE USING COLD INSULIN. SHE FELT GOOD AND BLOOD GLUCOSE LEVEL WAS "OK", BUT SHE DOES NOT HAVE CONFIDENCE IN THE INSULIN DELIVERY OF THE INFUSION DEVICE. PATIENT WAS TREATED IN THE INTENSIVE CARE UNIT FROM (B)(6) 2011 AND WAS THEN TRANSFERRED TO THE REGULAR CARE UNIT. DATE OF DISCHARGE AND TREATMENT PROVIDED BY THE HOSPITAL WERE NOT PROVIDED. PATIENT MIGHT HAVE HAD AN INFECTION, AND HER NORMAL BLOOD GLUCOSE LEVEL IS 120 MG/DL. INFUSION DEVICE WAS NOT EXPOSED TO WATER OR ELECTROMAGNETIC FIELDS. INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVALUATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    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 44 YR Hospitalization| R INSULIN INFUSION SET| INSULIN