BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD RAPID DETECTION OF SARS-COV-2 VERITOR ASSAY

    MDR report key: 10663161 · Received October 12, 2020

    Report

    Report Number
    1119779-2020-00563
    Event Type
    Malfunction
    Date Received
    October 12, 2020
    Date of Event
    September 17, 2020
    Report Date
    October 13, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    QKP
    UDI-DI
    00382902560821
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY : THIS STATEMENT IS TO SUMMARIZE THE INVESTIGATION RESULTS REGARDING THE COMPLAINT THAT ALLEGES FALSE POSITIVE RESULTS WHEN USING KIT RAPID DETECTION OF SARS-COV-2 VERITOR (MATERIAL # 256082), BATCH NUMBER 0233466. BD QUALITY PERFORMS A SYSTEMATIC APPROACH TO INVESTIGATE FALSE POSITIVE/DISCREPANT RESULTS COMPLAINTS. THIS APPROACH INVOLVES REVIEW OF MANUFACTURING BATCH HISTORY RECORDS, TESTING OF RETENTION SAMPLES, AND TESTING OF CUSTOMER RETURNED SAMPLES, IF APPLICABLE. AN INVESTIGATION AND TESTING WERE PERFORMED ON THE BATCH NUMBER PROVIDED. THE REPORTED ISSUE WAS UNABLE TO BE CONFIRMED. HOWEVER, THERE IS A TREND AGAINST FALSE POSITIVE RESULTS. BD HAS INITIATED CAPA (CORRECTIVE AND PREVENTIVE ACTION) # 1878253 TO FURTHER INVESTIGATE. THE ROOT CAUSE COULD NOT BE IDENTIFIED. BD QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    BD WAS MADE AWARE OF A SURVEY THAT WAS DISTRIBUTED TO SKILLED NURSING FACILITIES USING THE VERITOR ANALYZER AND ASSAY FOR RAPID DETECTION OF SARS-COV-2. SURVEY RESULTS REVEALED THAT SOME FACILITIES HAVE POTENTIALLY RECEIVED FALSE POSITIVE RESULTS WHILE USING BD RAPID DETECTION OF SARS-COV-2 VERITOR ASSAY. SURVEY RESPONDENTS STATED THEY ARE SENDING POSITIVE SAMPLES FOR CONFIRMATION TESTING BY PCR. SOME OF THE SITES PARTICIPATING IN THE SURVEY STATED THEY ARE TESTING ASYMPTOMATIC AND SYMPTOMATIC PATIENTS AND STAFF. NOTE: THIS TEST IS NOT INTENDED FOR USE ON ASYMPTOMATIC PATIENTS. ATTEMPTS HAVE BEEN MADE TO CONTACT CUSTOMERS FOR ADDITIONAL INFORMATION, BD HAS NOT RECEIVED A RESPONSE AT THIS TIME. EUA#: (B)(4).

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    BD WAS MADE AWARE OF A SURVEY THAT WAS DISTRIBUTED TO SKILLED NURSING FACILITIES USING THE VERITOR ANALYZER AND ASSAY FOR RAPID DETECTION OF SARS-COV-2. SURVEY RESULTS REVEALED THAT SOME FACILITIES HAVE POTENTIALLY RECEIVED FALSE POSITIVE RESULTS WHILE USING BD RAPID DETECTION OF SARS-COV-2 VERITOR ASSAY. SURVEY RESPONDENTS STATED THEY ARE SENDING POSITIVE SAMPLES FOR CONFIRMATION TESTING BY PCR. SOME OF THE SITES PARTICIPATING IN THE SURVEY STATED THEY ARE TESTING ASYMPTOMATIC AND SYMPTOMATIC PATIENTS AND STAFF. NOTE: THIS TEST IS NOT INTENDED FOR USE ON ASYMPTOMATIC PATIENTS. ATTEMPTS HAVE BEEN MADE TO CONTACT CUSTOMERS FOR ADDITIONAL INFORMATION, BD HAS NOT RECEIVED A RESPONSE AT THIS TIME. EUA#: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1131868 BD RAPID DETECTION OF SARS-COV-2 VERITOR ASSAY CORONAVIRUS ANTIGEN DETECTION SYSTEM QKP BECTON, DICKINSON & CO. (SPARKS) 233466 00382902560821

    Patients

    Seq Age Sex Outcome Treatment
    1 Other