BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® FLEXLINK INFUSION SET

    MDR report key: 7466151 · Received April 26, 2018

    Report

    Report Number
    3011393376-2018-01894
    Event Type
    Injury
    Date Received
    April 26, 2018
    Date of Event
    March 2, 2018
    Report Date
    May 6, 2019
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    FPA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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. THIS CASE, WITH PATIENT IDENTIFIER (B)(6), IS RELATED TO CASE WITH PATIENT IDENTIFIER (B)(6).

    Additional Manufacturer Narrative · 1

    THE CUSTOMER RETURNED THE PRODUCT TO THEIR LOCAL ROCHE AFFILIATE. THE AFFILIATE HAS NOT RETURNED THE PRODUCT TO THE MANUFACTURER AND IS UNABLE TO LOCATE THE PRODUCT TO RETURN IT NOW. THE MANUFACTURER TESTED RETENTION PRODUCT OF THE SAME LOT NUMBER AND ALL TESTING PASSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED AN ALLERGIC REACTION WITH THE FLEXLINK INFUSION SETS. THE CALLER REPORTED THAT TWO DAYS AFTER INSERTION OF THE CANNULA THE CUSTOMER'S SITE DISPLAYED SWELLING, REDNESS, AND A SECRETION OF PUS. THE CUSTOMER'S INSERTION SITE WAS ON THE STOMACH. ON (B)(6) 2018 THE CUSTOMER WENT TO THE DERMATOLOGIST. THE DERMATOLOGIST PERFORMED A CULTURE, AND DETERMINED THAT THE CUSTOMER HAD (B)(6) COAGULASE. THE CUSTOMER WAS PRESCRIBED CEPHALEXIN 500 MG/ 1 TABLET EVERY 6 HOURS FOR 7 DAYS. THE CALLER REPORTED THAT THIS OCCURRED WITH TWO DIFFERENT BOXES; LOT 5160978 - EXPIRY DATE 10/2018 AND LOT 5168723 - EXPIRY DATE 10/2018. THE INFUSION SETS WERE REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308696 ACCU-CHEK ® FLEXLINK INFUSION SET SUBCUTANEOUS INFUSION SET FPA ROCHE DIABETES CARE, INC. 5160978

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Required Intervention