BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® ULTRAFLEX INFUSION SET

    MDR report key: 4791727 · Received May 22, 2015

    Report

    Report Number
    3011393376-2015-00599
    Event Type
    Malfunction
    Date Received
    May 22, 2015
    Date of Event
    April 26, 2015
    Report Date
    January 6, 2016
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    FPA
    PMA / PMN Number
    K101196
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS RETURNED BY CUSTOMER TO ROCHE AFFILIATE. DEVICE WAS LOST IN TRANSPORT BETWEEN AFFILIATE AND INVESTIGATION UNIT AND WAS UNABLE TO BE LOCATED SO NO INVESTIGATION COULD BE PERFORMED. DEVICE LOST IN TRANSIT.

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INFUSION TUBING HAD DETACHED FROM HEADSET. NO ADVERSE EVENT WAS REPORTED. THE INFUSION SET WAS REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337021 ACCU-CHEK ® ULTRAFLEX INFUSION SET SUBCUTANEOUS INFUSION SET FPA ROCHE DIABETES CARE, INC. NA 5083496

    Patients

    Seq Age Sex Outcome Treatment
    1 009 YR