BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHECK SPIRIT

    MDR report key: 2871427 · Received December 5, 2012

    Report

    Report Number
    2183996-2012-01917
    Event Type
    Injury
    Date Received
    December 5, 2012
    Date of Event
    November 14, 2012
    Report Date
    November 30, 2012
    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
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2012, PT REPORTED SHE WAS HOSPITALIZED FOR HYPERGLYCEMIA. HER BLOOD GLUCOSE ELEVATED TO ABOUT 700 MG/DL, AND HER NORMAL BLOOD GLUCOSE IS 80-120 MG/DL. SHE WAS ADMITTED TO THE HOSPITAL AND RELEASED AFTER A "FEW DAYS." SHE WAS TAKEN OFF THE INFUSION DEVICE AND TREATED WITH AN INSULIN IV. SHE WAS TOLD SHE HAD AN INFECTION AND THIS CAUSED HYPERGLYCEMIA. SHE HAS NOT RESTARTED THE INFUSION DEVICE AND IS ON INJECTION THERAPY. NO ALLEGATIONS WERE MADE AGAINST THE INFUSION DEVICE OR RELATED PRODUCTS, AND NO ISSUES WERE FOUND DURING TROUBLESHOOTING. NO PRODUCT WILL BE RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHECK SPIRIT LZG ROCHE INSULIN DELIVERY SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization| R INSULIN| INSULIN INFUSION PUMP| RELATED ACCESSORIES