BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK GUIDE TEST STRIPS

    MDR report key: 11055301 · Received December 22, 2020

    Report

    Report Number
    3011393376-2020-04593
    Event Type
    Malfunction
    Date Received
    December 22, 2020
    Date of Event
    December 8, 2020
    Report Date
    January 21, 2021
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    NBW
    UDI-DI
    00365702701953
    PMA / PMN Number
    K160944
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS CASE, WITH PATIENT IDENTIFIER (B)(6) (SYSTEM 1), IS RELATED TO CASE WITH PATIENT IDENTIFIER (B)(6) (SYSTEM 2).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: ON (B)(6) 2020: 394 MG/DL, 248 MG/DL AND 173 MG/DL. ON (B)(6) 2020: 337 MG/DL, 160 MG/DL, 169 MG/DL, 469 MG/DL, 326 MG/DL AND 183 MG/DL. THE PATIENT WAS USING 2 LOTS OF TEST STRIPS AND DOES NOT KNOW WHICH LOT IS ASSOCIATED WITH WHICH READING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1521172 ACCU-CHEK GUIDE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS NBW ROCHE DIABETES CARE, INC. 07453736001 101717 00365702701953

    Patients

    Seq Age Sex Outcome Treatment
    1 464 YR