BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2233963 · Received August 31, 2011

    Report

    Report Number
    2183996-2011-02341
    Event Type
    Injury
    Date Received
    August 31, 2011
    Date of Event
    August 18, 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 HE WAS ON A MOTOR BIKE TOUR IN (B)(6) AND BECAME VERY SICK EARLY IN THE MORNING ON (B)(6) 2011. HE HAD NAUSEA AND DIARRHEA, AND HE VOMITED. BLOOD GLUCOSE WAS 483 MG/DL, AND HE DELIVERED 6 I.E. VIA THE INFUSION DEVICE. THIS WAS NOT SUCCESSFUL IN LOWERING HIS BLOOD GLUCOSE. BLOOD GLUCOSE ELEVATED TO 486 MG/DL, AND HE DELIVERED ANOTHER 6 I.E. VIA THE INFUSION DEVICE. PATIENT WAS TRANSPORTED TO THE HOSPITAL BY AMBULANCE, AND BLOOD GLUCOSE WAS 371 MG/DL. HOSPITAL DELIVERED 6 I.E. OF INSULIN THROUGH A HOSPITAL INFUSION DEVICE, AND BLOOD GLUCOSE DECREASED TO 106 MG/DL. PATIENT RECEIVED STATIONARY TREATMENT FROM (B)(6) 2011. PATIENT RESTARTED HIS OWN INFUSION DEVICE ON (B)(6) 2011 AND HIS BLOOD GLUCOSE IS TOO LOW. HOSPITAL FOUND PATIENT HAS PROBLEMS WITH HIS PROSTATE GLAND. INFUSION NEEDLE IS CHANGED EVERY 2 DAYS AND THE TUBE AND CARTRIDGE ARE CHANGED EVERY WEEK. INFUSION DEVICE WAS NOT EXPOSED TO WATER. NORMAL BLOOD GLUCOSE IS 80-150 MG/DL. INFUSION DEVICE WAS REQUESTED FOR EVALUATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    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 76 YR Hospitalization| R INSULIN (DATE OF TX (B)(6) 2011)| INSULIN INFUSION SET| (DATE OF TX (B)(6) 2011)