BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® PERFORMA TEST STRIPS

    MDR report key: 15507657 · Received September 29, 2022

    Report

    Report Number
    3011393376-2022-02866
    Event Type
    Malfunction
    Date Received
    September 29, 2022
    Date of Event
    September 8, 2022
    Report Date
    October 28, 2022
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    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 SETS OF RESULTS WITHIN 15 MINUTES: (B)(6) 2022; 193 MG/DL (PATIENT METER) AND 95 MG/DL (PROFESSIONAL METER) (B)(6) 2022; 181 MG/DL (PATIENT METER) AND 80 MG/DL (PROFESSIONAL METER) (B)(6) 2022; 183 MG/DL (PATIENT METER) AND 90 MG/DL (PROFESSIONAL METER) (B)(6) 2022; 174 MG/DL (PATIENT METER) AND 95 MG/DL (PROFESSIONAL METER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1584033 ACCU-CHEK ® PERFORMA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS NBW ROCHE DIABETES CARE, INC. 670098

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Female