BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2120340 · Received June 2, 2011

    Report

    Report Number
    2183996-2011-01549
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    May 4, 2011
    Report Date
    May 9, 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

    THE PATIENT'S HUSBAND REPORTED THE PATIENT'S INFUSION DEVICE DISPLAYED E5 (END OF LIFE) AND SHE SWITCHED TO HER SECOND INFUSION DEVICE ON (B)(6) 2011. ON (B)(6) 2011, THE PATIENT'S BLOOD GLUCOSE MEASURED UNDER 30 MG/DL. SHE WAS APPROACHABLE BUT VERY CONFUSED AND DISORIENTED. HER HUSBAND GAVE HER ORAL GLUCOSE AND CALLED FOR AN AMBULANCE. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND TREATED IN THE INTENSIVE CARE UNIT AND SHE DISCONNECTED FROM THE INFUSION DEVICE. SOME TIME LATER, HER BLOOD GLUCOSE INCREASED TO 180 MG/DL AND SHE RECONNECTED TO THE INFUSION DEVICE. WITHIN A FEW MINUTES, HER BLOOD GLUCOSE MEASURED 30 MG/DL. SHE DISCONTINUED USE OF THE INFUSION DEVICE. SHE BELIEVES THE INFUSION DEVICE DELIVERS TOO MUCH INSULIN. HER NORMAL BLOOD GLUCOSE LEVEL IS 100 MG/DL. THE INFUSION DEVICE WAS REQUESTED TO BE RETURNED FOR EVALUATION.

    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 30 YR Hospitalization| R INSULIN INFUSION SET| INSULIN