BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK PERFORMA TEST STRIPS

    MDR report key: 10206123 · Received June 29, 2020

    Report

    Report Number
    3011393376-2020-02247
    Event Type
    Malfunction
    Date Received
    June 29, 2020
    Date of Event
    June 2, 2020
    Report Date
    November 5, 2020
    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

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES ON (B)(6) 2020: 57 MG/DL ON PERFORMA CONNECT AND 495 MG/DL ON PERFORMA COMBO. IT WAS REPORTED THE PATIENT ALSO RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES ON (B)(6) 2020: 68 MG/DL ON PERFORMA CONNECT AND 274 MG/DL ON PERFORMA COMBO. THE SAME VIAL OF TEST STRIPS WAS USED FOR BOTH SETS OF RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670084 ACCU-CHEK PERFORMA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS NBW ROCHE DIABETES CARE, INC. 478167

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR