BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    A1CNOW SELF CHECK

    MDR report key: 19670761 · Received July 3, 2024

    Report

    Report Number
    1836135-2024-00024
    Event Type
    Malfunction
    Date Received
    July 3, 2024
    Date of Event
    June 3, 2024
    Report Date
    July 3, 2024
    Manufacturer
    PTS DIAGNOSTICS
    Product Code
    PDJ
    UDI-DI
    00381933070019
    PMA / PMN Number
    K090413
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED WASHING THEIR FACE AFTER EXPOSURE WHICH IS THE PROPER MEASURE PER THE SAFETY DATA SHEET. THE CUSTOMER DID NOT REQUIRE FURTHER AID. RISK OF EXPOSURE IS LIMITED TO IRRITATION OF THE SITE (PARTICULARLY ON PROLONGED CONTACT). THIS EVENT IS BEING REPORTED OUT OF AN ABUNDANCE OF CAUTION DUE TO THE EXPOSURE AREA. QC RETENTION COMPONENTS WERE INSPECTED. NO MANUFACTURING DEFECTS WERE OBSERVED AND NO FLUID LEAK OR SPLASH WAS OBSERVED DURING TESTING.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT WHEN ATTEMPTING TO PERFORM A TEST WITH THEIR A1C KIT, THE SHAKER SOLUTION SPLASHED ONTO THEIR FACE UPON COLLECTOR INSERTION. THERE WERE NO ALLEGATIONS OF PATIENT/USER HARM DURING OR AFTER THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478487 A1CNOW SELF CHECK A1C CLINICAL ANALYZER PDJ PTS DIAGNOSTICS 2320644 00381933070019

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown