BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2800165 · Received October 17, 2012

    Report

    Report Number
    2183996-2012-01554
    Event Type
    Malfunction
    Date Received
    October 17, 2012
    Date of Event
    September 18, 2012
    Report Date
    October 2, 2012
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2012 THE PT REPORTED EXPERIENCING BLOOD GLUCOSE OF 200-300 MG/DL FOR THE PAST MONTH. HIS NORMAL BLOOD GLUCOSE LEVEL IS 120 MG/DL. HE TREATS ELEVATED BLOOD GLUCOSE BY BOLUSING. TROUBLESHOOTING DID NOT REVEAL ANY PRODUCT ISSUES. THE PT WAS ADVISED TO SWITCH TO HIS BACKUP INFUSION DEVICE FOR PURPOSES OF TROUBLESHOOTING. UPON F/U ON (B)(6) 2012 THE PT REPORTED THAT HE SWITCHED TO ANOTHER INFUSION DEVICE AND HIS BLOOD GLUCOSE RETURNED TO NORMAL. HE BELIEVES THE INFUSION DEVICE IS NOT DELIVERING ENOUGH INSULIN. THE PT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION DEVICE AND ADAPTER WERE REQUESTED TO BE RETURNED FOR EVAL. THE INSULIN CARTRIDGE AND INFUSION SET HAD BEEN DISCARDED.

    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 63 YR INSULIN| INSULIN INFUSION PUMP| RELATED ACCESSORIES