BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® PERFORMA TEST STRIPS

    MDR report key: 11952520 · Received June 7, 2021

    Report

    Report Number
    3011393376-2021-01730
    Event Type
    Malfunction
    Date Received
    June 7, 2021
    Date of Event
    May 10, 2021
    Report Date
    January 4, 2022
    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 · 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) (SYSTEM 1), IS RELATED TO CASE WITH PATIENT IDENTIFIER (B)(6) (SYSTEM 2).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES ON (B)(6) 2021: 87 MG/DL (SYSTEM 1) AND 507 MG/DL (SYSTEM 2). THE PATIENT ALSO RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES ON (B)(6) 2021: 85 MG/DL (SYSTEM 1) AND 235 MG/DL (SYSTEM 2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    847550 ACCU-CHEK ® PERFORMA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS NBW ROCHE DIABETES CARE, INC. 479213

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Male