BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ULTRAFLEX INFUSION SET

    MDR report key: 1030733 · Received April 17, 2008

    Report

    Report Number
    2183996-2008-00488
    Event Type
    Injury
    Date Received
    April 17, 2008
    Date of Event
    April 1, 2008
    Report Date
    April 2, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    FPA
    PMA / PMN Number
    K070189
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IN 2008, A COMPANY REPRESENTATIVE REPORTED THAT THE PATIENT EXPERIENCED ELEVATED BLOOD GLUCOSE OF OVER 600 MG/DL. HE STATED THAT HE CHANGED HIS INSULIN CARTRIDGE BEFORE HE LEFT FOR WORK AND HIS BLOOD GLUCOSE BEGAN TO ELEVATE. WHEN HE RETURNED HOME HIS BLOOD GLUCOSE WAS OVER THE LIMIT THAT HIS BLOOD GLUCOSE MONITOR WOULD READ. HE STATED THAT THERE WAS INSULIN POOLING IN THE CARTRIDGE COMPARTMENT OF THE INFUSION DEVICE. UPON FOLLOW UP WITH THE PATIENT IN 2008, THE PATIENT STATED THAT THE INFUSION TUBING WAS LOOSENED CAUSING INSULIN TO LEAK. HE REPLACED THE INFUSION TUBING AND HIS BLOOD GLUCOSE RETURNED TO NORMAL BY 11 PM. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO PRODUCT WILL 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 6J049UF

    Patients

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