BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2803772 · Received October 19, 2012

    Report

    Report Number
    2183996-2012-01612
    Event Type
    Injury
    Date Received
    October 19, 2012
    Date of Event
    October 7, 2012
    Report Date
    October 10, 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
    AL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2012, PATIENT REQUESTED ASSISTANCE REVIEWING THE BASAL RATES ON THE INFUSION DEVICE. HE HAS EXPERIENCED HYPOGLYCEMIA (32-40 MG/DL) FOR THE PAST MONTH, AND HE HAS BEEN ABLE TO SELF-TREAT WITH ORANGE JUICE. HIS BLOOD GLUCOSE DECREASED TO 26 MG/DL ON (B)(6) 2012, AND HE REQUIRED OUTSIDE ASSISTANCE. HIS WIFE GAVE HIM ORANGE JUICE AND GLUCOSE TABLETS TO TREAT HYPOGLYCEMIA. HIS NORMAL BLOOD GLUCOSE IS 100-125 MG/DL. NO PRODUCT ISSUES WERE REVEALED DURING TROUBLESHOOTING. HE REPORTED HIS DIET HAS CHANGED. HE SPOKE WITH HIS DOCTOR AND WAS ADVISED TO DECREASE THE BASAL RATES TO 24.6 UNITS PER DAY. THREE ADDITIONAL ATTEMPTS WERE MADE TO FOLLOW-UP WITH THE PATIENT, AND THESE WERE NOT SUCCESSFUL. NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    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 64 YR Required Intervention INSULIN| RELATED ACCESSORIES| INSULIN INFUSION PUMP