BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2021626 · Received March 10, 2011

    Report

    Report Number
    2183996-2011-00503
    Event Type
    Injury
    Date Received
    March 10, 2011
    Date of Event
    October 1, 2010
    Report Date
    February 15, 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
    PA, 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) 2011, PATIENT REPORTED AN ONGOING CONCERN WITH ERRATIC BLOOD GLUCOSE. THIS OCCURRED WHEN ON INJECTION THERAPY AND SINCE STARTING THE INFUSION DEVICE. SHE IS WORKING WITH PHYSICIAN ON INSULIN REQUIREMENTS AND WHAT SHE SHOULD EAT. PATIENT HAD TO RECEIVE TREATMENT AT THE HOSPITAL IN (B)(6) 2010, DUE TO A LOW BLOOD GLUCOSE READING OF APPROXIMATELY 20 MG/DL. PATIENT WAS ADMITTED FOR A FEW HOURS AND WAS GIVEN AN IV TO RAISE BLOOD GLUCOSE. ON THE DAY OF THE REPORT, BLOOD GLUCOSE WAS IN THE 300 MG/DL RANGE. TARGET BLOOD GLUCOSE IS 80-120 MG/DL. THERE WERE NO AIR BUBBLES IN THE INFUSION SET AND INSULIN DRIPPED FROM THE TUBING AS EXPECTED. INFUSION SET AND INSULIN CARTRIDGE ARE CHANGED EVERY 3 DAYS, AND BLOOD GLUCOSE TYPICALLY ELEVATES ON THE SECOND OR THIRD DAY OF USE. PATIENT WAS ADVISED ON INFUSION SITE ROTATION. INSULIN POOLED AROUND THE INFUSION SITE APPROXIMATELY 1 MONTH AGO, AND THE ADHESIVE WAS DAMP. HER BLOOD GLUCOSE DECREASED WHEN THE HEADSET WAS CHANGED. PATIENT ADVISED SHE WOULD CHANGE HER INFUSION SITE WHEN THE CALL ENDED. FOLLOW-UP WAS COMPLETED ON (B)(6) 2011. PATIENT REPORTED SHE DELIVERED A BOLUS AFTER THE PREVIOUS CALL, AND SHE COULD FEEL IT BEING DELIVERED. PATIENT REPORTED ERRATIC BLOOD GLUCOSE WAS DUE TO SOMETHING ELSE, "JUST THE CHEMISTRY IN MY BODY." BLOOD GLUCOSE WAS NORMAL AT TIME OF FOLLOW-UP. NO PRODUCT WAS REQUESTED FOR EVALUATION.

    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 60 YR Hospitalization| R INSULIN INFUSION SET: ((B)(6))| INSULIN: ((B)(6))