BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD RAPID DETECTION OF SARS-COV-2 VERITOR ASSAY

    MDR report key: 10959872 · Received December 7, 2020

    Report

    Report Number
    1119779-2020-01148
    Event Type
    Malfunction
    Date Received
    December 7, 2020
    Date of Event
    September 9, 2020
    Report Date
    September 21, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    QKP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: THIS 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 UNKNOWN. BD QUALITY PERFORMS A SYSTEMATIC APPROACH TO INVESTIGATE FALSE POSITIVE COMPLAINTS. THIS APPROACH INVOLVES REVIEW OF MANUFACTURING BATCH HISTORY RECORDS, TESTING OF RETENTION SAMPLES, AND TESTING OF CUSTOMER RETURNED SAMPLES, IF APPLICABLE. AN INVESTIGATION COULD NOT BE PERFORMED AS NO BATCH NUMBER OR AN INCORRECT BATCH NUMBER WAS PROVIDED. THE COMPLAINT 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. BD QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING FOR SARS COV-2 A FALSE POSITIVE RESULT WAS OBTAINED. A REPEAT TEST WAS PERFORMED USING PCR AND THE RESULT WAS NEGATIVE. THE CUSTOMER STATED THEY ARE TESTING ASYMPTOMATIC PATIENTS. THIS TEST IS NOT INTENDED FOR USE ON ASYMPTOMATIC PATIENTS AND WAS THEREFORE USED OFF LABEL. THE CUSTOMER STATED RESULTS WERE REPORTED OUT, BUT THERE WAS NO PATIENT IMPACT. EUA#: (B)(4).

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4). MEDICAL DEVICE LOT #: 0220417 WAS REPORTED, HOWEVER, THIS IS NOT A LOT# MANUFACTURED FOR THIS PRODUCT #. FDA NOTIFIED?: THE INITIAL REPORTER ALSO NOTIFIED THE FDA ON (DATE) VIA MEDWATCH # MW5097006.

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE TESTING FOR SARS COV-2 A FALSE POSITIVE RESULT WAS OBTAINED. A REPEAT TEST WAS PERFORMED USING PCR AND THE RESULT WAS NEGATIVE. THE CUSTOMER STATED THEY ARE TESTING ASYMPTOMATIC PATIENTS. THIS TEST IS NOT INTENDED FOR USE ON ASYMPTOMATIC PATIENTS AND WAS THEREFORE USED OFF LABEL. THE CUSTOMER STATED RESULTS WERE REPORTED OUT, BUT THERE WAS NO PATIENT IMPACT. EUA#: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1421639 BD RAPID DETECTION OF SARS-COV-2 VERITOR ASSAY CORONAVIRUS ANTIGEN DETECTION SYSTEM QKP BECTON, DICKINSON & CO. (SPARKS) 0220417

    Patients

    Seq Age Sex Outcome Treatment
    1