BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    A1CNOW+ PROFESSIONAL TEST KIT

    MDR report key: 20240582 · Received September 17, 2024

    Report

    Report Number
    1836135-2024-00033
    Event Type
    Malfunction
    Date Received
    September 17, 2024
    Date of Event
    August 19, 2024
    Report Date
    September 17, 2024
    Manufacturer
    PTS DIAGNOSTICS
    Product Code
    PDJ
    UDI-DI
    00391933021011
    PMA / PMN Number
    K090413
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UPON INVESTIGATION INCLUDING INSPECTION OF RETENTION MATERIAL, PTS DIAGNOSTICS COULD NOT VERIFY THE ALLEGATION OF NON-MATCHING CARTRIDGES AND COMPONENTS WITHIN THE TEST SYSTEM BOX. IT IS IMPORTANT TO NOTE THAT THE PRODUCT INSTRUCTIONS FOR USE/QUICK REFERENCE GUIDE STATE FIVE SEPARATE TIMES TO NOT USE CARTRIDGES THAT DO NOT MATCH THE ANALYZER CODE, WHICH PROMPTED COMPLAINTS FROM THE THREE CUSTOMERS PRIOR TO USE OF THE DEVICE. TO THE BEST OF OUR KNOWLEDGE, NO ADVERSE EVENTS HAVE BEEN REPORTED BECAUSE OF THIS ISSUE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE PRINTED CODE ON THE ANALYZER AND CARTRIDGE FROM THEIR KIT DID NOT MATCH. THE CUSTOMER REPORTED THEY HAVE ONE KIT IN THEIR POSSESSION AND THAT THE BOX WAS SEALED UPON DELIVERY. THERE WERE NO ALLEGATIONS OF PATIENT/USER HARM OR INACCURATE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2521502 A1CNOW+ PROFESSIONAL TEST KIT HBA1C TEST SYSTEM PDJ PTS DIAGNOSTICS 2323019 00391933021011

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown