BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    A1CNOW+ PROFESSIONAL TEST KIT

    MDR report key: 12092411 · Received June 30, 2021

    Report

    Report Number
    1836135-2021-00018
    Event Type
    Malfunction
    Date Received
    June 30, 2021
    Date of Event
    June 1, 2021
    Report Date
    June 30, 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 RECEIVING INACCURATE TEST RESULTS WHEN USING THE A1CNOW+ KIT WITH UP TO 3% VARIATION WHEN COMPARED TO A LAB DRAW. THERE WERE NO ALLEGATIONS OF PATIENT/USER HARM. CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE MALFUNCTIONED, AS THE DEVICE WAS NOT RETURNED. ADDITIONALLY, QC RETENTION TESTING MEASURED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED RECEIVING INACCURATE TEST RESULTS WHEN USING THE A1CNOW+ KIT WITH UP TO 3% VARIATION WHEN COMPARED TO A LAB DRAW. THERE WERE NO ALLEGATIONS OF PATIENT/USER HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    991560 A1CNOW+ PROFESSIONAL TEST KIT CLINICAL CHEMISTRY ANALYSER PDJ PTS DIAGNOSTICS 3021 2017714 00381933021011

    Patients

    Seq Age Sex Outcome Treatment
    1