BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ULTRAFLEX INFUSION SET

    MDR report key: 1062252 · Received June 17, 2008

    Report

    Report Number
    2183996-2008-00878
    Event Type
    Malfunction
    Date Received
    June 17, 2008
    Date of Event
    June 11, 2008
    Report Date
    June 11, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    FPA
    PMA / PMN Number
    K070189
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCTS WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    THE PT REPORTED HE RECEIVED AN E4 (OCCLUSION) MESSAGE ON HIS INSULIN INFUSION DEVICE THIS MORNING. TO TROUBLESHOOT, THE PT WAS INSTRUCTED TO DISCONNECT FROM HIS DEVICE AND PERFORM A PRIME WHICH WENT THROUGH WITHOUT ERROR. THE PT WAS INSTRUCTED TO REMOVE HIS INSULIN SET BUT COULD NOT DO SO, AS HE WAS AT WORK AND DID NOT HAVE AN EXTRA INFUSION SET. HE STATED HE WOULD RETURN HOME AND CHANGE HIS INFUSION SET. ON FOLLOW UP THE SAME DAY, THE PT STATED WHEN HE REMOVED THE INFUSION SET THE CANNULA WAS BENT. HE STATED, THE OCCLUSION MESSAGE CLEARED AS SOON AS HE INSERTED A NEW INFUSION SET. THE PT SAID HE THREW AWAY THE INFUSION SET. NO PHYSIOLOGICAL EFFECT WAS REPORTED. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO PRODUCT WAS AVAILABLE TO BE RETURNED FOR EVALUATION.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR INSULIN INFUSION PUMP| INSULIN