BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1449958 · Received August 20, 2009

    Report

    Report Number
    2183996-2009-01772
    Event Type
    Injury
    Date Received
    August 20, 2009
    Date of Event
    June 30, 2009
    Report Date
    July 21, 2009
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    ON 07/21/2009, THE PT'S NURSE REQUESTED ADDITIONAL TRAINING FOR THE PT. THE PT HAS BEEN EXPERIENCING ELEVATED BLOOD GLUCOSE FOR 2-3 WEEKS. THE INFUSION DEVICE HAS NOT DISPLAYED ANY ERROR MESSAGES AND THERE WERE NO LEAKS IN THE SYSTEM. HER INSULIN WAS CLEAR AND HAD NOT BEEN EXPOSED TO EXTREME TEMPERATURES. THE PT WAS NOT ABLE TO COMPLETE TROUBLESHOOTING AT THE TIME OF THE INITIAL REPORT. ON 07/21/2009, THE PT CALLED BACK TO COMPLETE TROUBLESHOOTING. SHE ATTEMPTED TO REVIEW THE BOLUS HISTORY OF THE INFUSION DEVICE, BUT SHE WAS UNABLE TO COMPLETE THE STEPS. HER INSULIN CARTRIDGE, INFUSION SITE AND TUBING HAD BEEN CHANGED. SHE STATED THAT HER BLOOD GLUCOSE WAS ELEVATED TO ALMOST 600 MG/DL TODAY. HER NORMAL BLOOD GLUCOSE LEVEL IS BELOW 150 MG/DL. A REQUEST FOR ADDITIONAL TRAINING WAS SUBMITTED. PER TRAINER'S NOTES ON 08/06/2009, THE PT DENIES HAVING ISSUES WITH HER INFUSION DEVICE. HER BASAL RATES WERE ADJUSTED A "FEW" DAYS AGO BY HER ENDOCRINOLOGIST, AND HER BLOOD GLUCOSE HAS IMPROVED. 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 65 YR Other| R INSULIN| INSULIN INFUSION SET