BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ULTRAFLEX INFUSION SET

    MDR report key: 1231704 · Received November 14, 2008

    Report

    Report Number
    2183996-2008-01719
    Event Type
    Injury
    Date Received
    November 14, 2008
    Date of Event
    October 2, 2008
    Report Date
    October 16, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    FPA
    PMA / PMN Number
    K070189
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE PT REPORTED THAT SHE HAS BEEN EXPERIENCING OCCLUSION (E4) ERRORS FOR THE PAST 2 WEEKS. SHE STATED THAT THE ISSUE BEGAN WITH THE LAST 4 INFUSION SETS IN THE BOX SHE WAS USING. HER PHYSICIAN GAVE HER A NEW BOX OF INFUSION SETS AND SHE CONTINUES TO HAVE THE SAME ISSUE. AFTER CHANGING THE INFUSION SET, SHE RECEIVES HER BASAL RATES FOR 1.5-2 HOURS AND THEN BEGINS TO RECEIVE E4 ERRORS. SHE IS ONLY ABLE TO CLEAR THE ERROR BY CHANGING THE INFUSION TUBING. SHE CHANGES HER INFUSION SITE AND TUBING EVERY 2-3 DAYS. THE PT STATED THAT DUE TO THE ERRORS, HER BLOOD GLUCOSE HAS ELEVATED TO OVER 600 MG/DL AND SHE FEELS HORRIBLE AND IS BREATHING HARD. SHE INJECTED 35 UNITS OF INSULIN TO LOWER HER BLOOD GLUCOSE. SHE USES HER ABDOMEN AS AN INFUSION SITE AND SHE ROTATES SITES UP AND DOWN AND FROM SIDE TO SIDE. SHE STATED THAT SHE DOES HAVE SOME SCAR TISSUE. SHE WAS SENT REPLACEMENT INFUSION SETS. THE PT CALLED BACK ON THE NEXT DAY AND STATED THAT SHE EXPERIENCED ANOTHER E4 AT 4:50 AM. SHE CHANGED THE INFUSION TUBING AND WAS ABLE TO CLEAR THE ERROR. SHE STATED THAT SHE BEGAN USE OF THE INFUSION DEVICE LATE 2007 AND HAS NEVER CHANGED THE ADAPTER. SHE WAS ADVISED TO CHANGE THE ADAPTER. THE PT CALLED BACK ON SIX DAYS AFTER THE ORIGINAL DATE AND STATED THAT SHE CHANGED THE ADAPTER AND THE ERRORS CONTINUE. HER BLOOD GLUCOSE WAS ELEVATED TO 559 MG/DL WHEN SHE WOKE UP. SHE WAS ABLE TO LOWER IT TO 197 MG/DL. SHE WAS ADVISED TO SWITCH TO HER BACKUP INFUSION DEVICE USING THE SAME ACCESSORIES. LATER ON THAT DAY, THE PT REPORTED THAT SHE SWITCHED TO HER BACKUP INFUSION DEVICE AT 2:00 PM USING THE SAME ACCESSORIES AS WITH THE PRIMARY DEVICE AND SHE RECEIVED AN E4 AT 2:15 PM. SHE CHANGED ALL OF THE ACCESSORIES AND WAS ABLE TO CLEAR THE ERROR. UPON FOLLOW UP ON THE FOLLOWING MONTH, THE PT STATED THAT SHE CONTINUED TO EXPERIENCE E4 ERRORS WITH HER BACKUP INFUSION DEVICE. SHE BEGAN TO FILL A NEW INSULIN CARTRIDGE AND NOTICED THAT THE INSULIN WAS LIKE "GEL". SHE BEGAN USING A NEW VIAL OF INSULIN AND HAS HAD NO FURTHER ISSUES. THE PT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REQUESTED TO BE RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ULTRAFLEX INFUSION SET INSULIN INFUSION SET FPA DISETRONIC MEDICAL SYSTEMS NA 6F158UF

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R INSULIN INFUSION PUMP| INSULIN