BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1241777 · Received November 20, 2008

    Report

    Report Number
    2183996-2008-01707
    Event Type
    Injury
    Date Received
    November 20, 2008
    Date of Event
    April 1, 2007
    Report Date
    October 22, 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
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE PT'S HUSBAND REPORTED THAT THE PT IS EXPERIENCING ELEVATED BLOOD GLUCOSE OF 500 MG/DL AND SHE SWITCHED TO INJECTION THERAPY. THE HUSBAND WAS NOT ABLE TO PROVIDE DETAILS OF THE EVENT AND HE DID NOT HAVE THE INFUSION DEVICE TO TROUBLESHOOT. UPON FOLLOW UP WITH THE PT THE NEXT DAY, SHE STATED THAT FOR THE LAST 18 MOS SHE HAS EXPERIENCED CHRONIC ELEVATED BLOOD GLUCOSE THAT RANGES FROM 200-600 MG/DL AND SHE BELIEVES HER INFUSION DEVICE IS NOT PROPERLY DELIVERING INSULIN. SHE STATED THAT THE INSULIN CARTRIDGE DOES NOT SEEM TO SIT CORRECTLY IN THE INFUSION DEVICE AND "THE FLANGE THAT IS INSIDE THE CARTRIDGE DOES NOT SEEM TO MOVE BECAUSE IT DOES NOT GO IN THE PUMP CORRECTLY". THE PT DID NOT RECEIVE ANY ERROR MESSAGES ON THE INFUSION DEVICE AND THE TIME AND BASAL RATES ARE PROGRAMMED CORRECTLY. FURTHER ATTEMPTS TO FOLLOW UP WITH THE PT WERE UNSUCCESSFUL. THE PT DID NOT REQUIRE MEDICAL 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 42 YR Other| R INSULIN INFUSION SET| INSULIN