BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK INFUSION SET

    MDR report key: 11653174 · Received April 12, 2021

    Report

    Report Number
    3011393376-2021-01179
    Event Type
    Malfunction
    Date Received
    April 12, 2021
    Date of Event
    April 7, 2021
    Report Date
    June 23, 2021
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    FPA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED OUTSIDE OF THE UNITED STATES. WHILE THIS PRODUCT IS NOT SOLD IN THE UNITED STATES, IT IS LIKE OR SIMILAR TO A PRODUCT MARKETED IN THE UNITED STATES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INFUSION SET WAS LEAKING AT THE HEADSET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551046 ACCU-CHEK FLEXLINK INFUSION SET SUBCUTANEOUS INFUSION SET FPA ROCHE DIABETES CARE, INC. ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN INSULIN