BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1241796 · Received November 20, 2008

    Report

    Report Number
    2183996-2008-01746
    Event Type
    Injury
    Date Received
    November 20, 2008
    Date of Event
    October 30, 2008
    Report Date
    October 30, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON THE EVENT DATE, THE PATIENT REPORTED SHE SPILLED AN ENTIRE CARTRIDGE OF INSULIN INSIDE THE CARTRIDGE CHAMBER OF HER INSULIN INFUSION DEVICE. SHE STATED SHE HAS HAD ELEVATED BLOOD GLUCOSE READINGS OF "HI" ALL DAY WITH HER NORMAL RANGE BEING 120-140 MG/DL. SHE SAID HER ONLY SYMPTOMS IS THIRST. THE PATIENT WAS ADVISED TO SWITCH TO HER BACKUP INFUSION DEVICE. ON FOLLOW UP WITH THE PATIENT ONE WEEK LATER, SHE STATED HER BLOOD GLUCOSE HAS RETURNED TO HER NORMAL RANGE. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED AND 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 58 YR Other| R INSULIN| INSULIN INFUSION SET