BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ULTRAFLEX INFUSION SET

    MDR report key: 1243180 · Received November 7, 2008

    Report

    Report Number
    2183996-2008-01695
    Event Type
    Malfunction
    Date Received
    November 7, 2008
    Date of Event
    October 21, 2008
    Report Date
    October 21, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    FPA
    PMA / PMN Number
    K033892
    Removal / Correction Number
    Z-1116/1146-6
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    ON (B) (6) 2008, THE PATIENT REPORTED THAT HE CHECKED HIS INFUSION TUBING CONNECTION TODAY AND FOUND THAT THE OUTER TUBING HAD SEPARATED AT THE LUER LOCK. HE STATED THAT NO INSULIN WAS LEAKING AND HIS BLOOD GLUCOSE WAS NOT AFFECTED. THE INFUSION TUBING HAD BEEN IN USE SINCE (B) (6) 2008. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO PRODUCT WAS REQUESTED 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 5I005UF

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR INSULIN INFUSION PUMP| INSULIN