BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1063327 · Received June 19, 2008

    Report

    Report Number
    2183996-2008-00894
    Event Type
    Injury
    Date Received
    June 19, 2008
    Date of Event
    June 5, 2008
    Report Date
    June 5, 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
    IA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE PT REPORTED ELEVATED BLOOD GLUCOSE READINGS UP TO 450 MG/DL DUE TO HIS BEING UNABLE TO GIVE HIMSELF A BOLUS OF INSULIN THROUGH HIS INFUSION DEVICE. SYMPTOMS WERE FEELING SLUGGISH AND TIRED, AND HE TREATED HIS READINGS BY GIVING HIMSELF INJECTIONS OF INSULIN. THE PT STATED WHEN HE TRIED TO GIVE HIMSELF A BOLUS, THE UP BUTTON ON HIS INFUSION DEVICE WOULD NOT WORK. HE STATED THE DOWN BUTTON IS ALSO NOT PROPERLY FUNCTIONING AND THAT THE BUTTONS STARTED TO ACT "FUNNY" ABOUT A WEEK AGO. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED AND REQUESTED TO BE RETURNED FOR EVAL.

    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| INSULIN INFUSION SET