BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2071810 · Received April 21, 2011

    Report

    Report Number
    2183996-2011-01141
    Event Type
    Injury
    Date Received
    April 21, 2011
    Date of Event
    March 22, 2011
    Report Date
    March 22, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS, INC.
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL METHOD AND RESULTS: NO PRODUCT WILL BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    ON (B)(6) 2011, PT REPORTED THAT HER BLOOD GLUCOSE WAS ABOVE 500 MG/DL AND SHE WAS DEHYDRATED, THROWING UP, AND FELT VERY ILL. PT DELIVERED A CORRECTION BOLUS AND HER BLOOD GLUCOSE STARTED TO DECREASE. PT WAS ENCOURAGED BY COMPANY REP TO SEEK MEDICAL ATTENTION. COMPANY REP LEFT A MESSAGE WITH PT'S CLINICAL TRAINER. F/U WAS COMPLETED WITH PT APPROXIMATELY 12 HOURS LATER, AND PT REPORTED THAT SHE JUST GOT OUT OF THE HOSPITAL. SHE WAS TREATED WITH FLUIDS AND WAS KEPT IN THE EMERGENCY ROOM FOR APPROX 3 HOURS. PT WAS NOT GIVEN ANY INSULIN AT THE HOSPITAL. NORMAL BLOOD GLUCOSE RANGE IS 150-190 MG/DL. NO ERROR MESSAGES WERE RECEIVED ON THE INFUSION DEVICE. INFUSION SET, CARTRIDGE, ADAPTER, AND BATTERY WERE USED PER SPECIFICATION. TROUBLESHOOTING DID NOT REVEAL ANY PRODUCT CONCERNS. F/U WAS COMPLETED WITH PT ON (B)(6) 2011. PT REPORTED SHE DOES NOT KNOW WHAT CAUSED HYPERGLYCEMIA, AND THE HOSPITAL WAS NOT ABLE TO FIND THE CAUSE EITHER. NO PRODUCT WAS REQUESTED FOR EVAL.

    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