BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU CHECK SPIRIT

    MDR report key: 1842824 · Received September 15, 2010

    Report

    Report Number
    2183996-2010-01930
    Event Type
    Injury
    Date Received
    September 15, 2010
    Date of Event
    August 22, 2010
    Report Date
    September 3, 2010
    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

    (METHOD AND RESULTS) - NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    ON (B)(6)2010, THE PT CALLED FOR ASSISTANCE VIEWING TOTAL DAILY INSULIN AMOUNTS ON THE INFUSION DEVICE. SHE REPORTED EXPERIENCING LOW BLOOD GLUCOSE DURING THE PAST WEEK AND EMERGENCY PERSONNEL WERE CALLED TO HER HOME 2 TIMES. SHE STATED, HER PHYSICIAN CHANGED HER INSULIN 3 WEEKS AGO AND SHE BELIEVED THIS COULD BE THE REASON FOR LOW BLOOD GLUCOSE. SHE STATED SHE MAY HAVE OVER BOLUSED ON ONE OCCASION BUT NOT THE OTHER INCIDENTS. SHE HAS BEEN IN CONTACT WITH HER PHYSICIAN REGARDING THE LOW BLOOD GLUCOSE AND THEY ARE WORKING TO ADJUST HER BASAL RATES. SHE STATED THIS MORNING AT 6:00AM, HER BLOOD GLUCOSE MEASURED 88MG/DL AND SHE ATE AND BOLUSED 2 UNITS OF INSULIN AT 6:30AM. SHE STATED SHE WOULD HAVE NORMALLY BOLUSED 2.3-2.5 UNITS FOR THIS MEAL. AT 8:20AM, SHE FELT LIKE HER BLOOD GLUCOSE WAS LOW AND SHE ATE A CHOCOLATE BAR. AT 9:00AM HER BLOOD GLUCOSE MEASURED 42MG/DL. SHE DRANK A GLUCOSE DRINK TO ELEVATE HER READINGS. AT THE TIME OF THE REPORT, HER BLOOD GLUCOSE MEASURED 61 MG/DL. HER NORMAL BLOOD GLUCOSE LEVEL IS 100 MG/DL. UPON F/U ON (B)(6)2010, THE PT STATED SHE CONTINUES TO WORK WITH HER PHYSICIAN TO ADJUST HER BASAL RATES AND IS NOT A "LITTLE ON THE HIGH SIDE" BUT FEELING FINE. NO PRODUCT WAS REQUESTED TO BE RETURNED FOR EVALUATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention INSULIN| INSULIN INFUSION SET