BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT CARTRIDGE

    MDR report key: 1291608 · Received January 13, 2009

    Report

    Report Number
    2183996-2008-02026
    Event Type
    Injury
    Date Received
    January 13, 2009
    Date of Event
    December 16, 2008
    Report Date
    December 16, 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
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IN LATE 2008, THE PT REPORTED EXPERIENCING ELEVATED BLOOD GLUCOSE OF 201-248 MG/DL AND THERE WERE AIR BUBBLES IN THE INSULIN CARTRIDGE AND INFUSION TUBING. HER NORMAL BLOOD GLUCOSE LEVEL IN 115-120 MG/DL. SYMPTOMS OF ELEVATED BLOOD GLUCOSE ARE THIRST, FREQUENT URINATIONS, AND "DON'T FEEL RIGHT." THE INSULIN CARTRIDGE AND INFUSION SET WERE CHANGED TODAY. SHE STATED THAT SHE DOES ALLOW INSULIN TO REACH ROOM TEMPERATURE PRIOR TO USE AND SHE ADJUSTS THE PISTON ROD OF THE INFUSION DEVICE PRIOR TO INSERTION. THE PT WAS ADVISED TO DISCONNECT FROM THE INFUSION SITE AND TO PRIME THE BUBBLES FROM THE SYSTEM. UPON FOLLOW UP THIRTEEN DAYS LATER, THE PT STATED THAT SHE AGAIN SAW AIR BUBBLES IN THE INFUSION TUBING, BUT SHE BELIEVED IT WAS DUE TO INSULIN "BACKING UP" IN THE TUBING CAUSED BY A BENT INFUSION SITE CANNULA (REPORTED SEPARATELY). 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 EVALUATION.

    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 56 YR Required Intervention INSULIN| INSULIN INFUSION PUMP| INSULIN INFUSION SET