BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK GUIDE TEST STRIPS

    MDR report key: 10758323 · Received October 29, 2020

    Report

    Report Number
    3011393376-2020-03926
    Event Type
    Malfunction
    Date Received
    October 29, 2020
    Date of Event
    October 26, 2020
    Report Date
    January 21, 2021
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    NBW
    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. THIS CASE, WITH PATIENT IDENTIFIER (B)(6) (TEST STRIP LOT NUMBER 101784), IS RELATED TO CASE WITH PATIENT IDENTIFIER (B)(6) (TEST STRIP LOT NUMBER 101586).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 33 MG/DL (TEST STRIP LOT NUMBER 101784) AND 94 MG/DL (TEST STRIP LOT NUMBER 101586).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1219531 ACCU-CHEK GUIDE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS NBW ROCHE DIABETES CARE, INC. 101784

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR