BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    A1CNOW+ PROFESSIONAL TEST KIT

    MDR report key: 12092421 · Received June 30, 2021

    Report

    Report Number
    1836135-2021-00017
    Event Type
    Malfunction
    Date Received
    June 30, 2021
    Date of Event
    May 10, 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 ACCURACY CONCERNS WHEN USING THE A1CNOW+. THE CUSTOMER REPORTED RECEIVING A RESULT OF 12.6% ON THE A1CNOW+ COMPARED TO A LAB RESULTS OF 6% ON THE SAME DAY. THERE WERE NO ALLEGATIONS OF PATIENT/USER HARM. DURING TROUBLESHOOTING IT WAS DETERMINED THAT THE CUSTOMER WAS NOT FOLLOWING THE INSTRUCTIONS AS WELL AS TESTING PATIENTS THAT WERE IDENTIFIED UNDER THE "LIMITATIONS" SECTION OF THE PACKAGE INSERT. QC RETAINS MEASURED WITHIN SPECIFICATION AND THE CUSTOMER COMPLAINT COULD NOT BE DUPLICATED. DUE TO HUMAN ERROR AT COMPLAINT RECEIPT, THIS ITEM WAS NOT FLAGGED AS A PMDR UNTIL AFTER THE DATE BY WHICH IT SHOULD HAVE BEEN REPORTED. A CAPA HAS BEEN ISSUED ACCORDINGLY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ACCURACY CONCERNS WHEN USING THE A1CNOW+. THE CUSTOMER REPORTED RECEIVING A RESULT OF 12.6% ON THE A1CNOW+ COMPARED TO A LAB RESULTS OF 6% ON THE SAME DAY. THERE WERE NO ALLEGATIONS OF PATIENT/USER HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    991567 A1CNOW+ PROFESSIONAL TEST KIT CLINICAL CHEMISTRY ANALYZER PDJ PTS DIAGNOSTICS 3021 00381933021011

    Patients

    Seq Age Sex Outcome Treatment
    1