BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT CARTRIDGE

    MDR report key: 1231657 · Received November 14, 2008

    Report

    Report Number
    2183996-2008-01712
    Event Type
    Injury
    Date Received
    November 14, 2008
    Date of Event
    October 25, 2008
    Report Date
    November 1, 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
    IL, 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 1 WEEK AGO SHE USED AN ENTIRE INSULIN CARTRIDGE IN ONE DAY DUE TO ISSUES WITH AIR BUBBLES AND HER BLOOD GLUCOSE WAS ELEVATED TO 300-325 MG/DL. SHE STATED THAT SHE BOLUSED BUT HER BLOOD GLUCOSE DID NOT DECREASE. THIS IS WHEN SHE DISCOVERED AIR BUBBLES IN THE INFUSION TUBING. HER TARGET BLOOD GLUCOSE RANGE IS 125-150 MG/DL. SHE WAS ABLE TO BOLUS TO LOWER HER BLOOD GLUCOSE. THE PT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO PRODUCT WAS REQUESTED TO 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 INFUSION PUMP| INSULIN| INSULIN INFUSION SET