BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® PERFORMA TEST STRIPS

    MDR report key: 16130787 · Received January 10, 2023

    Report

    Report Number
    3011393376-2023-00074
    Event Type
    Malfunction
    Date Received
    January 10, 2023
    Date of Event
    December 3, 2022
    Report Date
    February 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 14 MG/DL AND 328 MG/DL. ON DIFFERENT DATES THE CUSTOMER TESTED WITHIN 15 MINUTES WITH THE SAME LOT: (B)(6) 2022 - 30 MG/DL, 49 MG/DL, AND 506 MG/DL; (B)(6) 2022 - 47 MG/DL AND 304 MG/DL; (B)(6) 2022 - 48 MG/DL AND 226 MG/DL; (B)(6) 2022 - 38 MG/DL AND 357 MG/DL; (B)(6) 2022 - 31 MG/DL AND 198 MG/DL; (B)(6) 2022 - 12 MG/DL AND 392 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195111 ACCU-CHEK ® PERFORMA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS NBW ROCHE DIABETES CARE, INC. 670123

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Female