BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® PERFORMA TEST STRIPS

    MDR report key: 14934001 · Received July 6, 2022

    Report

    Report Number
    3011393376-2022-01966
    Event Type
    Malfunction
    Date Received
    July 6, 2022
    Date of Event
    June 24, 2022
    Report Date
    September 14, 2022
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PM
    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 WITH SYSTEM 1: 442 MG/DL AT 5:38 P.M., 87 MG/DL AT 5:39 P.M., 105 MG/DL AT 5:40 P.M., AND 99 MG/DL AT 5:42 P.M. IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES ON (B)(6) 2022: 35 MG/DL (SYSTEM 1) AT 7:40 AND 89 MG/DL (SYSTEM 2) AT 7:40.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    913864 ACCU-CHEK ® PERFORMA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS NBW ROCHE DIABETES CARE, INC. 480071

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Female HUMALOG INSULIN| TRESIBA INSULIN