BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1915766 · Received November 29, 2010

    Report

    Report Number
    2183996-2010-02500
    Event Type
    Injury
    Date Received
    November 29, 2010
    Date of Event
    November 13, 2010
    Report Date
    November 18, 2010
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTMES INC.
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    Z-1415-2009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    PT REPORTED THE UP ARROW ON HER INFUSION DEVICE IS NOT WORKING. PT STATED THE RUBBER IS PEELING OFF OF THE INFUSION DEVICE AND NOW THE UP ARROW BUTTON IS NOT RESPONDING. PT REPORTED SHE NOTICED THE ISSUE THIS WEEKEND WHEN SHE WAS ATTEMPTING TO BOLUS. PT STATED HER BLOOD GLUCOSE WAS ELEVATED AROUND 400 MG/DL WHEN SHE NOTICED THE UP ARROW WAS NOT RESPONDING. PT'S NORMAL BLOOD GLUCOSE IS 140 MG/DL. PT REPORTED SHE SWITCHED TO HER BACKUP INFUSION DEVICE TO TREAT HERSELF AND HER BLOOD GLUCOSE REGULATED BACK TO NORMAL. PT STATED SHE DID 3 INFUSION SITE CHANGES AND CHANGED HER INSULIN CARTRIDGE BEFORE REALIZING THE UP ARROW BUTTON WAS NOT RESPONDING. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED AND REQUESTED RETURN OF THE ALLEGED PRODUCT FOR EVALUATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention INSULIN INFUSION SET| INSULIN