BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IDNOW COVID-19

    MDR report key: 11466983 · Received March 11, 2021

    Report

    Report Number
    1221359-2021-00699
    Event Type
    Injury
    Date Received
    March 11, 2021
    Report Date
    April 26, 2021
    Manufacturer
    ABBOTT DIAGNOSTICS SCABOROUGH
    Product Code
    QJR
    PMA / PMN Number
    EUA2000074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER REPORTED THE ELUTION BUFFER GOT IN HER EYE. TECHNICAL SERVICES VERIFIED THAT THE OPERATOR WAS EXAMINED AFTER THE ISSUE AND SHE WAS FINE. CUSTOMER WANTED TO CONFIRM IF THE POSITIVE PATIENT SAMPLE WAS CONTAGIOUS TO HER NOW THAT IT HAD BEEN ELUTED INTO THE SAMPLE RECEIVER AND HAD SPLASHED INTO HER EYE. TS INFORMED CUSTOMER THEY WOULD NOT CONTRACT COVID-19 FROM ELUTION BUFFER. ACCORDING TO THE PACKAGE INSERT IN190000 V6.0: 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 · 0

    THE REPORTED EVENT IS ANTICIPATED IN NATURE AND SEVERITY FOR BINAXNOW COVID-19 AG CARD AND CAPTURED WITHIN THE PRODUCT'S RISK MANAGEMENT FILE. THE CUSTOMER WAS ADVISED OF NOT CONTRACTING COVID-19 FROM ELUTION BUFFER AND WAS PROVIDED WITH DOCUMENTATION OF ID NOW BIOHAZARD SAFEGUARDS. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU): 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

    THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ACCIDENTALLY GETTING THE IDNOW COVID-19 ELUTION BUFFER IN THEIR EYE FROM A POSITIVE PATIENT SAMPLE ON DATE OF TEST UNKNOWN. THE CUSTOMER WAS CONCERNED ABOUT SARS-COV-2 TRANSMISSION AND INFECTION FROM THIS SAMPLE. THE CUSTOMER CONFIRMED SHE WAS EXAMINED AFTER THE EVENT AND "WAS FINE.". ATTEMPTS TO GAIN FURTHER INFORMATION WERE UNSUCCESSFUL. DUE TO CURRENT STUDIES SUGGESTING THAT THE EYE IS A POTENTIAL ROUTE FOR SARS-COV-2 TRANSMISSION AND INFECTION, ALBEIT LOW RISK COMPARED TO OTHER ROUTS OF INFECTION, MEDICAL OPINION DETERMINED THIS EVENT SHALL BE REPORTABLE. ADDITIONALLY, PER MEDICAL OPINION, REGARDLESS OF WHETHER OR NOT THE SAMPLE WAS POSITIVE FOR THE VIRUS, THIS EVENT IS CONSIDERED TO BE REPORTABLE DUE TO THE ELUTION BUFFER COMING INTO CONTACT WITH THE EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358263 IDNOW COVID-19 MOLECULAR IVD FOR IDNOW COVID-19 QJR ABBOTT DIAGNOSTICS SCABOROUGH

    Patients

    Seq Age Sex Outcome Treatment
    1 Other