BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    A1CNOW+ PROFESSIONAL TEST KIT

    MDR report key: 11983789 · Received June 11, 2021

    Report

    Report Number
    1836135-2021-00012
    Event Type
    Malfunction
    Date Received
    June 11, 2021
    Date of Event
    May 12, 2021
    Report Date
    June 9, 2021
    Manufacturer
    PTS DIAGNOSTICS
    Product Code
    PDJ
    UDI-DI
    00381933021011
    PMA / PMN Number
    K090413
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THE ANALYZER WAS NOT DISPLAYING RESULTS IN NGSP UNITS AS PRINTED ON THE ANALYZER. THERE WERE NO ALLEGATIONS OF PATIENT/USER HARM. THE ANALYZER HAS RECENTLY BEEN RECEIVED AND THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE ANALYZER WAS NOT DISPLAYING RESULTS IN NGSP UNITS AS PRINTED ON THE ANALYZER. THERE WERE NO ALLEGATIONS OF PATIENT/USER HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    884253 A1CNOW+ PROFESSIONAL TEST KIT CLINICAL CHEMISTRY ANALYZER PDJ PTS DIAGNOSTICS 3021 2028627 00381933021011

    Patients

    Seq Age Sex Outcome Treatment
    1