BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAFLEX INFUSION SET

    MDR report key: 756631 · Received July 28, 2006

    Report

    Report Number
    2183996-2006-00592
    Event Type
    Malfunction
    Date Received
    July 28, 2006
    Date of Event
    January 1, 2006
    Report Date
    July 14, 2006
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS, INC.
    Product Code
    FPA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT HE RECEIVED A BOX OF ACCU-CHEK ULTRAFLEX INFUSION SETS THAT CONTAIN A DISETRONIC INFUSION SET MIXED WITH THE ACCU-CHEK ULTRAFLEX INFUSION SETS. THE TWO INFUSION SETS ARE NOT COMPATIBLE. THE PATIENT REPORTED HE IDENTIFIED THIS ISSUE WHEN HE ATTEMPTED TO SNAP THE TWO DIFFERENT BRANDS TOGETHER. BOTH PRODUCTS ARE EXPIRED. THE PATIENT DID NOT REPORT ANY PHYSIOLOGICAL EVENT ASSOCIATED WITH THIS ISSUE. NO MEDICAL TREATMENT WAS REQUIRED. THE PRODUCT WAS REQUESTED TO BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT HE RECEIVED A BOX OF ACCU-CHEK ULTRAFLEX INFUSION SETS THAT CONTAIN A DISETRONIC INFUSION SET MIXED WITH THE ACCU-CHEK ULTRAFLEX INFUSION SETS. THE TWO INFUSION SETS ARE NOT COMPATIBLE. THE PATIENT REPORTED HE IDENTIFIED THIS ISSUE WHEN HE ATTEMPTED TO SNAP THE TWO DIFFERENT BRANDS TOGETHER. BOTH PRODUCTS ARE EXPIRED. THE PATIENT DID NOT REPORT ANY PHYSIOLOGICAL EVENT ASSOCIATED WITH THIS ISSUE. NO MEDICAL TREATMENT WAS REQUIRED. THE PRODUCT WAS REQUESTED TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAFLEX INFUSION SET INSULIN INFUSION SET FPA DISETRONIC MEDICAL SYSTEMS, INC. ULTRAFLEX 41145UF

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR INSULIN INFUSION PUMP| INSULIN,