BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1052848 · Received May 27, 2008

    Report

    Report Number
    2183996-2008-00770
    Event Type
    Injury
    Date Received
    May 27, 2008
    Date of Event
    May 7, 2008
    Report Date
    May 7, 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
    OK, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    THE PT REPORTED AN ELEVATED BLOOD GLUCOSE READING OF 500 MG/DL WITH HIS NORMAL RANGE BEING APPROX 80-160 MG/DL. HE STATED HIS SYMPTOM WAS NAUSEA AND HE GAVE HIMSELF INSULIN INJECTIONS TO CORRECT HIS READINGS. TO TROUBLESHOOT, THE PT WAS INSTRUCTED TO CHECK THE TIME AND BASAL RATES ON HIS INSULIN INFUSION DEVICE WHICH HE CONFIRMED TO BE ACCURATE. THE PT STATED HE CHANGES HIS INSULIN INFUSION HEADSET EVERY 3 DAYS. THE PT WAS ADVISED HE SHOULD CHANGE HIS TYPE OF HEADSETS EVERY 2 DAYS. THE PT STATED HE REUSES HIS CARTRIDGES AND WAS ADVISED THE CARTRIDGES ARE TO BE USED ONE TIME ONLY. COMPLIMENTARY INFUSION SETS WERE SENT TO THE PT. ON FOLLOW UP, THE PT STATED HIS READINGS ARE NOT COMPLETELY BACK TO NORMAL BUT HE HAS SPOKEN TO HIS DOCTOR WHO IS ADJUSTING HIS INSULIN USE. THE PRODUCT WAS REPLACED. NO PRODUCT WAS 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 Other| R INSULIN| INSULIN INFUSION SET