BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    A1CNOW SELF CHECK CHEMISTRY KIT

    MDR report key: 20270179 · Received September 20, 2024

    Report

    Report Number
    1836135-2024-00034
    Event Type
    Malfunction
    Date Received
    September 20, 2024
    Date of Event
    August 22, 2024
    Report Date
    September 20, 2024
    Manufacturer
    PTS DIAGNOSTICS
    Product Code
    PDJ
    UDI-DI
    00381933070019
    PMA / PMN Number
    K090417
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER HAS NOT RETURNED THE KIT FOR INVESTIGATION. BASED UPON THE DIFFERENCE BETWEEN THE A1C RESULTS AND THE LAB VALUE, THIS IS BEING REPORTED OUT OF AN ABUNDANCE OF CAUTION. ADDITIONAL FACTORS CONTRIBUTE TO A MEDICAL DECISION BEING MADE (I.E. SIGNS, SYMPTOMS, ADDITIONAL GATHERED DATA) AND A SIGNIFICANT DIFFERENCE WOULD RESULT IN A RETEST OR ADDITIONAL EVALUATION/TESTING. QC RETENTION TESTING MEASURED WITHIN SPECIFICATION.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED RECEIVING A LOW A1C RESULT FROM THEIR A1C NOW SELF CHECK KIT IN COMPARISON TO A LAB RESULT FROM OVER A MONTH PRIOR. THERE WERE NO ALLEGATIONS OF PATIENT/USER HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1801737 A1CNOW SELF CHECK CHEMISTRY KIT A1C CHEMISTRY KIT PDJ PTS DIAGNOSTICS 2405251 00381933070019

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown