BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® ULTRAFLEX INFUSION SET

    MDR report key: 3875263 · Received June 16, 2014

    Report

    Report Number
    1823260-2014-04384
    Event Type
    Malfunction
    Date Received
    June 16, 2014
    Date of Event
    May 18, 2014
    Report Date
    August 13, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FPA
    PMA / PMN Number
    K101196
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. NO PRODUCT AVAILABLE TO BE RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD TWO INFUSION SETS THAT WERE LEAKING AT THE HEADSET. THE PATIENT EXPERIENCED ELEVATED BLOOD GLUCOSE LEVELS. NO ADVERSE EVENT WAS REPORTED. THE INFUSION SETS WERE DISCARDED; THEREFORE, NO PRODUCT COULD BE REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352685 ACCU-CHEK ® ULTRAFLEX INFUSION SET SUBCUTANEOUS INFUSION SET FPA ROCHE DIAGNOSTICS NA 5052892

    Patients

    Seq Age Sex Outcome Treatment
    1