BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1183885 · Received October 1, 2008

    Report

    Report Number
    2183996-2008-01513
    Event Type
    Injury
    Date Received
    October 1, 2008
    Date of Event
    September 23, 2008
    Report Date
    September 24, 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
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    IN 2008, THE PT REPORTED THAT SHE BELIEVED HER INFUSION DEVICE WAS NOT DELIVERING INSULIN. AT 5:00 PM IN THE PREVIOUS DAY, HER BLOOD GLUCOSE MEASURED 418 MG/DL. SHE DISCONNECTED FROM HER INFUSION SITE AND CONFIRMED THAT INSULIN WAS FLOWING FROM THE END OF THE INFUSION TUBING. HER PHYSICIAN ADVISED HER TO INJECT 20 UNITS OF INSULIN AND HER BLOOD GLUCOSE DECREASED TO 66 MG/DL. SHE ATE AND HER BLOOD GLUCOSE ELEVATED TO 142 MG/DL. SHE REPORTED THAT THERE WAS A SMALL AIR BUBBLE IN THE INSULIN CARTRIDGE. BASAL RATES AND BOLUS AMOUNTS WERE REVIEWED AND CONFIRMED TO BE ACCURATE. PRIOR TO THE REPORT, THE PATIENT'S BLOOD GLUCOSE MEASURED 488 MG/DL. AT THE END OF THE CALL HER BLOOD GLUCOSE HAD DECREASED TO 379 MG/DL. HER NORMAL BLOOD GLUCOSE RANGE IS 140-200 MG/DL. SHE STATED THAT HER PHYSICIAN ADVISED HER TO BOLUS 5 UNITS OF INSULIN PRIOR TO EATING AND TO INJECT INSULIN TO CORRECT FOR ELEVATED BLOOD GLUCOSE. SHE STATED THAT HER BASAL RATES ARE STILL BEING ADJUSTED AND SHE HAS AN APPOINTMENT WITH HER PHYSICIAN ABOUT TWO WEEKS LATER. AT THE END OF THE CALL THE PT NO LONGER BELIEVED THE INFUSION DEVICE CONTRIBUTED TO ELEVATED BLOOD GLUCOSE READINGS. NO PRODUCT WILL 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 INFUSION SET| INSULIN