BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1012655 · Received March 11, 2008

    Report

    Report Number
    2183996-2008-00324
    Event Type
    Injury
    Date Received
    March 11, 2008
    Date of Event
    March 2, 2008
    Report Date
    March 2, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    THE PT REPORTED AN ELEVATED BLOOD GLUCOSE READING OF 390 MG/DL AT 5AM THIS MORNING. HE STATED HE "DIDN'T FEEL RIGHT" AND CORRECTED HIS READING BY BOLUSING 7 UNITS OF INSULIN AND THEN ANOTHER 3 UNITS. HE STATED HIS CURRENT BLOOD GLUCOSE READING IS 126 MG/DL. TROUBLESHOOTING WAS ATTEMPTED BUT DECLINED BY THE PT. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO PRODUCT WAS REQUESTED TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT INSULIN INFUSION PUMP LZG DISETRONIC MEDICAL SYSTEMS NA NA

    Patients

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