BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT CARTRIDGE

    MDR report key: 1202825 · Received October 14, 2008

    Report

    Report Number
    2183996-2008-01580
    Event Type
    Injury
    Date Received
    October 14, 2008
    Date of Event
    September 19, 2008
    Report Date
    September 19, 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
    CO, 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 SHE HAS BEEN EXPERIENCING ELEVATED BLOOD GLUCOSE READINGS UP TO 420-430 MG/DL DUE TO AIR BUBBLES IN THE CARTRIDGE OF HER INSULIN INFUSION DEVICE. SHE STATED HER NORMAL RANGE IS 80-120 MG/DL. HER ONLY SYMPTOM IS FREQUENT URINATION AND SHE CORRECTS HER READINGS BY PRIMING OUT THE AIR BUBBLES AND BOLUSING INSULIN. SHE STATED SHE WILL SOMETIME CHANGE HER INFUSION HEADSET, TUBING AND CARTRIDGE AS A PRECAUTION. SHE SAID SHE USES ROOM TEMPERATURE INSULIN TO FILL HER CARTRIDGES AND MAKES SURE ALL CONNECTIONS ARE TIGHT. THE PT AGREED TO HAVE ADDITIONAL TRAINING AND A REQUEST FOR ASSISTANCE WAS MADE. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO PRODUCT WILL BE RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT CARTRIDGE INSULIN INFUSION PUMP CARTRIDGE LZG DISETRONIC MEDICAL SYSTEMS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention INSULIN| INSULIN INFUSION PUMP| INSULIN INFUSION SET