BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® ULTRAFLEX INFUSION SET

    MDR report key: 4818053 · Received June 4, 2015

    Report

    Report Number
    3011393376-2015-00881
    Event Type
    Malfunction
    Date Received
    June 4, 2015
    Date of Event
    May 12, 2015
    Report Date
    July 15, 2015
    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
    SP
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6). WHILE THIS PRODUCT IS NOT SOLD IN THE UNITED STATES, IT IS LIKE OR SIMILAR TO A PRODUCT MARKETED IN THE UNITED STATES. SEE (B)(4) FOR LOT 5078640, SEE (B)(4) FOR LOT 5078642, SEE (B)(4) FOR LOT 5083495, SEE (B)(4) FOR LOT 5049863.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWICE, THE (B)(6), THE INFUSION SET BROKE. THE CUSTOMER WAS WITHOUT INSULIN AND PRESENTED AN INCREASE IN BLOOD GLUCOSE. PARENTS DO NOT KNOW THE LOT NUMBER OF THE INFUSION SETS. THEY HAVE FOUR DIFFERENT LOTS OF INFUSION SETS 5078640, 5078642, 5083495, 5049863. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362197 ACCU-CHEK ® ULTRAFLEX INFUSION SET SUBCUTANEOUS INFUSION SET FPA ROCHE DIABETES CARE, INC. NA 5049863

    Patients

    Seq Age Sex Outcome Treatment
    1 009 YR UNSPECIFIED INSULIN