BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD RAPID DETECTION OF SARS-COV-2 VERITOR

    MDR report key: 10975889 · Received December 9, 2020

    Report

    Report Number
    1119779-2020-01182
    Event Type
    Malfunction
    Date Received
    December 9, 2020
    Date of Event
    November 10, 2020
    Report Date
    October 17, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    QKP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: 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 PROVIDED WAS NOT VALID. 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#1878253 TO FURTHER INVESTIGATE. QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING FOR SARS-COV-2 2 FALSE POSITIVE RESULTS WERE OBTAINED. CONFIRMATORY TESTING WAS PERFORMED USING PCR TEST METHOD AND THE RESULTS WERE NEGATIVE. THE CUSTOMER STATED THE STAFF MEMBERS TESTED WERE ASYMPTOMATIC. THIS TEST IS NOT INTENDED FOR USE ON ASYMPTOMATIC PATIENTS AND WAS THEREFORE USED OFF LABEL. RESULTS WERE REPORTED TO PHYSICIAN. STAFF MEMBERS WERE SENT HOME TO QUARANTINE FOR 10 DAYS. EUA # (B)(4).

    Additional Manufacturer Narrative · 1

    EUA # (B)(4). MEDICAL DEVICE LOT #: 0260095 WAS REPORTED, HOWEVER, THIS IS NOT A LOT# MANUFACTURED FOR THIS PRODUCT. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE TESTING FOR SARS-COV-2 2 FALSE POSITIVE RESULTS WERE OBTAINED. CONFIRMATORY TESTING WAS PERFORMED USING PCR TEST METHOD AND THE RESULTS WERE NEGATIVE. THE CUSTOMER STATED THE STAFF MEMBERS TESTED WERE ASYMPTOMATIC. THIS TEST IS NOT INTENDED FOR USE ON ASYMPTOMATIC PATIENTS AND WAS THEREFORE USED OFF LABEL. RESULTS WERE REPORTED TO PHYSICIAN. STAFF MEMBERS WERE SENT HOME TO QUARANTINE FOR 10 DAYS. EUA # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1440170 BD RAPID DETECTION OF SARS-COV-2 VERITOR CORONAVIRUS ANTIGEN DETECTION SYSTEM QKP BECTON, DICKINSON & CO. (SPARKS) SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1