BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 12682541 · Received October 22, 2021

    Report

    Report Number
    1221359-2021-03262
    Event Type
    Injury
    Date Received
    October 22, 2021
    Report Date
    November 24, 2021
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    UDI-DI
    10811877011269
    PMA / PMN Number
    EUA2000074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF COMPLAINTS' TRENDS REVEALS THAT ALL LOTS WITHIN EXPIRY DATING ARE PERFORMING ACCORDING TO THE STATEMENTS MADE IN THE PACKAGE INSERT. ACCORDING TO THE PACKAGE INSERT : PRECAUTIONS 8. TREAT ALL SPECIMENS AS POTENTIALLY INFECTIOUS. FOLLOW UNIVERSAL PRECAUTIONS WHEN HANDLING SAMPLES, THIS KIT AND ITS CONTENTS. 14. SOLUTIONS USED TO MAKE THE POSITIVE CONTROL SWAB ARE INACTIVATED USING STANDARD METHODS. HOWEVER, PATIENT SAMPLES, CONTROLS, AND TEST PIECES SHOULD BE HANDLED AS THOUGH THEY COULD TRANSMIT DISEASE. OBSERVE ESTABLISHED PRECAUTIONS AGAINST MICROBIAL HAZARDS DURING USE AND DISPOSAL. 15. WEAR CLEAN PERSONAL PROTECTION EQUIPMENT AND GLOVES WHEN RUNNING EACH TEST. CHANGE GLOVES BETWEEN THE HANDLING OF SPECIMENS SUSPECTED OF COVID-19. 17. DO NOT OPEN THE SAMPLE RECEIVER BEFORE PLACING IN THE INSTRUMENT. IT WILL PROHIBIT THE ELUTION BUFFER FROM REACHING TEMPERATURE AND MAY IMPACT TEST PERFORMANCE. 18. IF THE SAMPLE RECEIVER IS SPILLED WHILE OPENING, CLEAN THE INSTRUMENT PER INSTRUCTIONS PROVIDED IN THE INSTRUMENT USER MANUAL AND CANCEL TEST. REPEAT TEST WITH A NEW SAMPLE RECEIVER.

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE PROVIDED. THE CUSTOMER WAS ADVISED TO SEEK MEDICAL ASSISTANCE FROM A PHYSICIAN TO GET CLEARANCE FROM ANY COVID-19 INFECTION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED GETTING SAMPLE RECEIVER SOLUTION INTO THEIR EYES WHILE COMPLETING THE ID NOW COVID-19 ASSAY. PER THE CUSTOMER, THEY FOLLOWED SAFETY DATA SHEET (SDS) INSTRUCTIONS TO ADDRESS THE ISSUE. PER THE CUSTOMER, THE NURSE WAS PERFORMING A COVID-19 TEST, AFTER MIXING THE SWAB IN THE SAMPLE RECEIVER SOLUTION, THE SAMPLE RECEIVER MOVED FROM THE INSTRUMENT AND AS THE NURSE WAS TRYING TO MOVE IT BACK INTO THE INSTRUMENT, THE SAMPLE RECEIVER SLIPPED FROM HER HANDS AND THE SOLUTION SPLASHED INTO HER EYES. PER THE CUSTOMER, THE NURSE'S EYES WERE BURNING AND THEY CONTACTED SDS AND FLUSHED HER EYES OUT WITH WATER FOR 15 MINUTES. AFTER FOLLOWING SDS SHEET THE NURSES EYES WERE NO LONGER BURNING OR RED. THE PATIENT SWAB GENERATED POSITIVE RESULTS. THE NURSE SAID SHE IS NOT SYMPTOMATIC AT THE MOMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1576480 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. M164613 10811877011269

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other