BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1020687 · Received March 28, 2008

    Report

    Report Number
    2183996-2008-00422
    Event Type
    Injury
    Date Received
    March 28, 2008
    Date of Event
    March 10, 2008
    Report Date
    March 11, 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
    GA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE PT REPORTED ERRATIC BLOOD GLUCOSE LEVELS THAT STARTED IN 2008 AFTER HE CHANGED HIS INSULIN CARTRIDGE AND INSULIN INFUSION SET. THE PT REPORTED HIS BLOOD GLUCOSE READINGS RANGED FROM 36 MG/DL TO 345 MG/DL WITH HIS NORMAL RANGE BEING 80-140 MG/DL. HE STATED HE TREATED HIS LOW READING BY EATING 2 SPOONFULS OF CREME FILLING AND TREATED HIS ELEVATED BLOOD GLUCOSE READINGS BY BOLUSING INSULIN THROUGH HIS INSULIN INFUSION DEVICE AND BY INJECTION. HE STATED HIS SYMPTOMS ARE BLURRED VISION AND NAUSEA. HE STATED HIS INFUSION DEVICE HAS NOT DISPLAYED ANY ERRORS/ALERTS. TO TROUBLESHOOT, THE PT WAS INSTRUCTED TO DISCONNECT FROM HIS INFUSION HEADSET AND TRY TO PERFORM A BOLUS. WHEN HE DID SO, HE NOTICED A LOT OF AIR BUBBLES IN THE INFUSION SET TUBING. HE SAID THE TUBING WAS NOT DAMAGED AND THERE WERE NO LEAKS. THE PT WAS ABLE TO PRIME ALL THE AIR BUBBLES OUT. THE PT THEN RECONNECTED TO HIS INFUSION HEADSET AND PUT HIS INSULIN INFUSION DEVICE INTO RUN. ON FOLLOW UP, THE PT SAID HE WAS STILL EXPERIENCING AIR BUBBLES. THE PT STATED HE HAD WORKED WITH THE TRAINER AND HE CONTINUES TO HAVE ISSUES WITH FILLING THE INSULIN CARTRIDGE IN A WAY, SO THAT HE DOES NOT GET AIR BUBBLES. IT WAS SUGGESTED THE PT SWITCH TO HIS BACKUP INFUSION DEVICE BUT HE DECLINED. THE PT ALSO DECLINED A REPLACEMENT INFUSION DEVICE. HE STATED HIS BLOOD GLUCOSE READINGS ARE BETWEEN 90 AND 135 MG/DL CURRENTLY WHILE HE IS ON INJECTION THERAPY AND HE WANTS TO REMAIN ON IT. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE PROD WAS REQUESTED TO BE RETURNED FOR EVAL.

    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 Required Intervention INSULIN INFUSION SET| INSULIN