BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2792185 · Received October 11, 2012

    Report

    Report Number
    2183996-2012-01534
    Event Type
    Injury
    Date Received
    October 11, 2012
    Date of Event
    September 28, 2012
    Report Date
    October 2, 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 REQUESTED ASSISTANCE DECREASING THE BASAL RATES ON THE INFUSION DEVICE FROM 12:00-3:00 A.M. PT REPORTED SHE HAD AN INSULIN REACTION ON (B)(64) 2012 AND BELIEVES SHE LOST CONSCIOUSNESS. SHE WOKE UP ON THE FLOOR AND FELT LOW, AND SHE WAS ABLE TO SELF-TREAT WITH 4 GLUCOSE TABLETS. SHE CHECKED HER BLOOD GLUCOSE AND IT WAS 31 MG/DL. SHE DRANK 8 OUNCES OF APPLE JUICE AND THEN BEGAN TO FEEL BETTER. HER NORMAL BLOOD GLUCOSE IS 138-155 MG/DL. PT IS UNSURE WHAT CAUSED THIS EVENT. HER BLOOD GLUCOSE WAS 159 MG/DL THE NIGHT BEFORE, AND SHE DELIVERED 2 UNITS OF INSULIN BASED ON THE BOLUS CALCULATOR. NO ALLEGATIONS WERE MADE AGAINST THE INFUSION DEVICE OR RELATED PRODUCTS, AND NO PRODUCT 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-CHEK SPIRIT LZG ROCHE INSULIN DELIVERY SYSTEMS INC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other INSULIN INFUSION PUMP| RELATED ACCESSORIES| INSULIN