BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1163069 · Received September 15, 2008

    Report

    Report Number
    2183996-2008-01418
    Event Type
    Injury
    Date Received
    September 15, 2008
    Date of Event
    September 8, 2008
    Report Date
    September 8, 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
    MT, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE PT REPORTED HIS PRIMARY INSULIN INFUSION DEVICE WAS PRIMING "IN BURSTS." HE STATED, HE NOTICED "PATTERNS" WITH HIS HAVING ELEVATED BLOOD GLUCOSE READINGS, SO HE SWITCHED TO HIS BACKUP INFUSION DEVICE. THE PT MENTIONED HE CHANGES HIS INSULIN INFUSION HEADSETS EVERY 5-6 DAYS AND WAS ADVISED, THE HEADSETS SHOULD BE CHANGED EVERY 2 DAYS. THE PT REFUSED TO TROUBLESHOOT. 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