BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1241780 · Received November 20, 2008

    Report

    Report Number
    2183996-2008-01744
    Event Type
    Injury
    Date Received
    November 20, 2008
    Date of Event
    October 7, 2008
    Report Date
    November 3, 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
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE PT REPORTED ELEVATED BLOOD GLUCOSE READINGS OF 350-400 MG/DL SINCE A MONTH PRIOR, WHEN SHE BEGAN INSULIN PUMP THERAPY. SHE STATED HER READINGS PRIOR TO PUMP THERAPY WAS 80-150 MG/DL. SYMPTOMS OF ELEVATED READINGS ARE FATIGUE AND SLUGGISHNESS. TROUBLESHOOTING DID NOT FIND ANY PRODUCT ISSUES. THE PT DECLINED A REPLACEMENT INFUSION DEVICE AS SHE HAS DECIDED PUMP THERAPY IS NOT CONDUCIVE TO HER LIFESTYLE. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. 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 61 YR Required Intervention INSULIN| INSULIN INFUSION SET