BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINITEST RAPID COVID-19 ANTIGEN SELF-TEST

    MDR report key: 17880001 · Received October 5, 2023

    Report

    Report Number
    3009238284-2023-00012
    Event Type
    Malfunction
    Date Received
    October 5, 2023
    Date of Event
    September 20, 2023
    Report Date
    October 5, 2023
    Manufacturer
    HEALGEN SCIENTIFIC
    Product Code
    QKP
    PMA / PMN Number
    EUA210639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER FAILED TO FOLLOW THE INSTRUCTIONS PROVIDED WITH THE DEVICE. UNDER THE WARNINGS, PRECAUTIONS, AND SAFETY INFORMATION SECTION OF THE PRODUCT INSTRUCTIONS, THE FOLLOWING IS STATED, ¿AVOID EXPOSURE OF YOUR SKIN, EYES, NOSE OR MOUTH TO THE SOLUTION IN THE TUBE.¿ QUICK REFERENCE INSTRUCTIONS ALSO MENTIONS TO MAKE SURE THERE IS A TIGHT FIT OF FILTER TIP TO THE TUBE. THE BUFFER SOLUTION IS NOT INTENDED TO COME IN CONTACT WITH THE PATIENT OR USER. PER THE SAFETY DATA SHEET, "NOT CLASSIFIED AS DANGEROUS ACCORDING TO DIRECTIVE (EC) NO. 1272/2008." CUSTOMER STATED THAT THEY DID NOT ENCOUNTER ANY HARM OR RECEIVE ANY MEDICAL INTERVENTION DUE TO THE EXPOSURE TO THE BUFFER SOLUTION. THE CAUSE OF THIS EVENT IS UNKNOWN.

    Description of Event or Problem · 0

    AS HOLDERS OF THE EMERGENCY USE AUTHORIZATION, SIEMENS HEALTHCARE DIAGNOSTICS IS SUBMITTING THIS REPORT ON BEHALF OF THE MANUFACTURER HEALGEN SCIENTIFIC. THE CUSTOMER REPORTED THAT 3 FILTER CAP TIPS WERE DEFECTIVE AND WOULD NOT ALLOW SAMPLE FLOW. ON THE NEXT NEW TIP, UPON SQUEEZING THE SAMPLE TUBE WITH HIGHER PRESSURE TO APPLY SAMPLE TO COVID TEST STRIP, THE SAMPLE MIXTURE SPLASHED OUT ONTO THE FACE AND COUNTER. THE CUSTOMER UPDATED THAT THEY DID NOT ENCOUNTER ANY HARM OR RECEIVE ANY MEDICAL INTERVENTION DUE TO THE EXPOSURE TO THE BUFFER SOLUTION. THERE WAS NO REPORTED INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2086935 CLINITEST RAPID COVID-19 ANTIGEN SELF-TEST COVID RAPID ANTIGEN SELF-TEST QKP HEALGEN SCIENTIFIC 2203195EUA

    Patients

    Seq Age Sex Outcome Treatment
    1 Male