BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT CARTRIDGE

    MDR report key: 1569291 · Received December 29, 2009

    Report

    Report Number
    2183996-2009-03068
    Event Type
    Injury
    Date Received
    December 29, 2009
    Date of Event
    November 30, 2008
    Report Date
    November 30, 2009
    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 2009, THE PATIENT REPORTED THAT AIR BUBBLES FORM IN THE INSULIN CARTRIDGE APPROXIMATELY 2 HOURS AFTER USE. THIS HAS BEEN ONGOING FOR ONE YEAR. SHE STATED THAT HER BLOOD GLUCOSE WAS ELEVATED TO 215 MG/DL AS A RESULT OF AIR BUBBLES. SHE CHANGED HER INFUSION SITE AND BOLUSED TO LOWER HER BLOOD GLUCOSE. HER TARGET BLOOD GLUCOSE LEVEL IS 150 MG/DL. SHE STATED SHE ALLOWS INSULIN TO REACH ROOM TEMPERATURE PRIOR TO USE. SHE STATED THAT SHE FILLS THE INSULIN CARTRIDGE TO 250-310 UNITS AND SHE MAKES SEVERAL ATTEMPTS TO PROPERLY ADJUST THE PISTON ROD TO MEET THE BOTTOM OF THE INSULIN CARTRIDGE. AT THE TIME OF THE REPORT, THERE WAS A "HUGE" AIR BUBBLE AT THE TOP OF THE INSULIN CARTRIDGE AND SHE STATED SHE WOULD PRIME IT FROM THE SYSTEM. UPON FOLLOW UP THE FOLLOWING MONTH, THE PATIENT STATED SHE CHANGED THE INSULIN CARTRIDGE TODAY AND CONTINUED TO EXPERIENCE AIR BUBBLES. SHE STATED SHE DOES NOT ATTACH THE INFUSION TUBING AND ADAPTER TO THE INSULIN CARTRIDGE PRIOR TO INSERTION AND SHE WAS ADVISED TO DO SO. FOUR DAYS LATER, THE PATIENT STATED THAT HER BLOOD GLUCOSE RETURNED TO NORMAL BUT SHE CONTINUES TO EXPERIENCE AIR BUBBLES. SHE STATED SHE WOULD CHANGE THE ADAPTER. ONE WEEK LATER, THE PATIENT REPORTED SHE HAD NO FURTHER ISSUES. THE PATIENT 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 SET| INSULIN INFUSION PUMP