BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® GUIDE TEST STRIPS

    MDR report key: 17061184 · Received June 5, 2023

    Report

    Report Number
    3011393376-2023-01291
    Event Type
    Malfunction
    Date Received
    June 5, 2023
    Date of Event
    May 24, 2023
    Report Date
    August 9, 2023
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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).

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 356 MG/DL (LOT.103678 ) AND 129 MG/DL (LOT.103540).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2324168 ACCU-CHEK ® GUIDE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS NBW ROCHE DIABETES CARE, INC. 103540

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female