BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ULTRAFEX INFUSION SET

    MDR report key: 1163430 · Received September 10, 2008

    Report

    Report Number
    2183996-2008-01350
    Event Type
    Malfunction
    Date Received
    September 10, 2008
    Date of Event
    August 23, 2008
    Report Date
    August 23, 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
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2008 THE PATIENT REPORTED THAT AN ENTIRE BOX OF INFUSION SETS HE RECEIVED HAD BENT INSERTION NEEDLES. HE STATED THAT THE INSERTION NEEDLES WAS "BENT BACKWARDS." THE PATIENT DID NOT USE ANY OF THE INFUSION SETS. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT 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 EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ULTRAFEX INFUSION SET INSULIN INFUSION SET FPA DISETRONIC MEDICAL SYSTEMS NA 7K220UF

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR INSULIN| INSULIN INFUSION PUMP