BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® PERFORMA TEST STRIPS

    MDR report key: 14835836 · Received June 27, 2022

    Report

    Report Number
    3011393376-2022-01887
    Event Type
    Malfunction
    Date Received
    June 27, 2022
    Date of Event
    June 5, 2022
    Report Date
    July 19, 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 · 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 ON (B)(6) 2022: 518 MG/DL AT 3:05 P.M., 17 MG/DL AT 3:06 P.M., AND 120 MG/DL AT 3:07 P.M. IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES ON (B)(6) 2022: 506 MG/DL AT 9:21 P.M. AND 87 MG/DL AT 9:22 P.M.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705290 ACCU-CHEK ® PERFORMA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS NBW ROCHE DIABETES CARE, INC. 670042

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Female