BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1041369 · Received May 8, 2008

    Report

    Report Number
    2183996-2008-00572
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    April 14, 2008
    Report Date
    April 14, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE PATIENT REPORTED SHE NOTICES AIR BUBBLES FORMING IN THE INSULIN CARTRIDGE OF HER INFUSION DEVICE WHEN THE INSULIN REMAINING REACHES APPROXIMATELY 200 UNITS. SHE STATED THIS HAS OCCURRED WITH EVERY CARTRIDGE FOR THE PAST 2 WEEKS. SHE SAID, SHE IS ABLE TO PRIME THE AIR BUBBLE OUT OF THE CARTRIDGE. DURING TROUBLESHOOTING, THE PT STATED SHE ALLOWS THE INSULIN TO REACH ROOM TEMPERATURE BEFORE USING IT BUT SHE DOES NOT CHANGE HER ADAPTER. THE PROPER PROCEDURE FOR CHANGING THE ADAPTER WAS REVIEWED WITH THE PT AND COURTESY ADAPTERS AND CARTRIDGES WERE SENT TO HER. ON FOLLOW UP, THE PT STATED SHE IS USING A NEW ADAPTER AND CARTRIDGE BUT IS STILL NOTICING AIR BUBBLES. SHE STATED, THERE ARE NO AIR BUBBLES WHEN SHE INSERTS THE CARTRIDGE BUT THEY APPEAR AFTER SHE HAS USED ABOUT 100 UNITS OF INSULIN. THE PT SAID SHE DOES NOT ADJUST THE PISTON ROD BEFORE INSERTING THE CARTRIDGE. THE PT WAS ADVISED ON HOW TO ADJUST THE PISTON ROD AND THE IMPORTANCE OF DOING SO. THE PT STATED THE ISSUE BEGAN AT THE SAME TIME SHE SWITCHED TO A DIFFERENT TYPE OF INSULIN. A TRAINER WAS SENT TO SEE THE PATIENT AND CONFIRMED THE PATIENT WAS FOLLOWING THE PROPER PROCEDURE FOR CHANGING THE CARTRIDGE. THE PT WAS ADVISED TO SWITCH TO HER BACKUP INFUSION DEVICE. ON FOLLOW UP, THE PT STATED SHE IS USING HER BACKUP DEVICE AND AT FIRST SAW ONLY TINY BUBBLES IN THE CARTRIDGE BUT THEN A LARGE BUBBLE APPEARED. SHE STATED SHE HAS USED BOTH THE OLD STYLE AND NEW STYLE CARTRIDGE AND HAS USED 2 DIFFERENT ADAPTERS. THE PT TRIED HER PRIMARY DEVICE AND SWITCHED BACK TO HER ORIGINAL TYPE OF INSULIN. SHE STATED SOME SMALL AIR BUBBLES FORMED BUT NO LARGE ONES. THE PT DID NOT REPORT BLOOD GLUCOSE CONCERNS RELATED TO THIS ISSUE. THE PT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE PRODUCT WAS REPLACED AND REQUESTED TO BE RETURNED FOR EVALUATION.

    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 INSULIN| INSULIN INFUSION SET