BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® GUIDE TEST STRIPS

    MDR report key: 15970100 · Received December 13, 2022

    Report

    Report Number
    3011393376-2022-03575
    Event Type
    Malfunction
    Date Received
    December 13, 2022
    Date of Event
    November 24, 2022
    Report Date
    February 9, 2023
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    NBW
    UDI-DI
    00365702712102
    PMA / PMN Number
    K160944
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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: 288 MG/DL AND 98 MG/DL. ON (B)(6) 2022, THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 312 MG/DL, 100 MG/DL, 127 MG/DL AND 137 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424726 ACCU-CHEK ® GUIDE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS NBW ROCHE DIABETES CARE, INC. 07453744001 103548 00365702712102

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Female