BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ULTRAFLEX INFUSION SET

    MDR report key: 1061648 · Received June 17, 2008

    Report

    Report Number
    2183996-2008-00883
    Event Type
    Injury
    Date Received
    June 17, 2008
    Date of Event
    June 4, 2008
    Report Date
    June 4, 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
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE PT REPORTED RECEIVING AN E4 (OCCLUSION) ERROR ON HER INFUSION DEVICE. HER BLOOD GLUCOSE ELEVATED TO 575 MG/DL AS A RESULT OF NOT BEING ABLE TO CLEAR THE ERROR. HER NORMAL BLOOD GLUCOSE LEVEL IS 120 MG/DL. SHE STATED THAT HER INFUSION SITE HAD BEEN IN USE FOR 3 DAYS AND HER INFUSION TUBING HAD BEEN IN USE FOR 6 DAYS. THE PT WAS INSTRUCTED TO CHANGE THE INFUSION SITE AND INFUSION TUBING. SHE WAS THEN ABLE TO PRIME THE INFUSION SET AND BOLUS TO LOWER HER BLOOD GLUCOSE. UPON FOLLOW UP THREE DAYS LATER, THE PT REPORTED THAT HER BLOOD GLUCOSE RETURNED TO NORMAL. THE PT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED AND 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 7J259UF

    Patients

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