BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® FLEXLINK INFUSION SET

    MDR report key: 4813585 · Received June 2, 2015

    Report

    Report Number
    3011393376-2015-00810
    Event Type
    Malfunction
    Date Received
    June 2, 2015
    Date of Event
    May 19, 2015
    Report Date
    December 29, 2015
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    FPA
    PMA / PMN Number
    NA
    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.

    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. CORRECTION: LOT NUMBER AND EXPIRATION DATE CHANGED TO ASKU. THE ACCU- CHEK ® FLEXLINK INFUSION SET WAS FROM ONE OF FOUR POSSIBLE LOT NUMBERS; 5083495, 5078640, 5078642, OR 5049863. THE CUSTOMER HAD PRODUCT FROM ALL FOUR OF THESE LOT NUMBERS AND IT WAS NOT POSSIBLE TO DETERMINE WHICH LOT NUMBER WAS IN USE AT THE TIME OF THE EVENT.

    Description of Event or Problem · 1

    REPORTER STATED THE INFUSION SET TUBE SEPARATED/BROKE NEAR THE LUER LOCK CONNECTION. THE CUSTOMER NOTICED THE ISSUE IMMEDIATELY, AND NO ADVERSE EVENT WAS REPORTED. THE ALLEGED PRODUCT WAS REQUESTED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355254 ACCU-CHEK ® FLEXLINK INFUSION SET SUBCUTANEOUS INFUSION SET FPA ROCHE DIABETES CARE, INC. NA 5078640

    Patients

    Seq Age Sex Outcome Treatment
    1 009 YR