BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1012663 · Received March 11, 2008

    Report

    Report Number
    2183996-2008-00305
    Event Type
    Injury
    Date Received
    March 11, 2008
    Date of Event
    February 25, 2008
    Report Date
    February 25, 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 PATIENT CALLED FOR ASSISTANCE IN SETTING UP HIS NEW INSULIN INFUSION DEVICE. HE REPORTED AN ELEVATED BLOOD GLUCOSE READING OF 240 MG/DL WITH HIS NORMAL RANGE BEING 100-140 MG/DL. HE STATED THIS WAS DUE TO BEING WITHOUT INSULIN WHILE TRYING TO SET UP HIS DEVICE. HE SAID HE TREATED HIS READING BY GIVING HIMSELF AN INJECTION OF 3 UNITS OF INSULIN. THE PATIENT WAS ASSISTED IN SETTING UP THE DEVICE. ON FOLLOW UP, THE PATIENT STATED HIS BLOOD GLUCOSE READINGS ARE STILL SOMEWHAT ELEVATED WHICH HE BELIEVES IS DUE TO HIS INFUSION SITE. HE STATED HE WILL CHANGE IT WHEN HE GETS HOME. THE PATIENT 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