BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD RAPID DETECTION OF SARS-COV-2 VERITOR

    MDR report key: 11761500 · Received May 3, 2021

    Report

    Report Number
    1119779-2021-00758
    Event Type
    Malfunction
    Date Received
    May 3, 2021
    Date of Event
    April 7, 2021
    Report Date
    December 2, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    QKP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D4: MEDICAL DEVICE LOT #: 1004994. H6: INVESTIGATION SUMMARY: THIS STATEMENT SUMMARIZES THE INVESTIGATION RESULTS REGARDING YOUR COMPLAINT THAT ALLEGES FALSE POSITIVE RESULTS WHEN USING KIT RAPID DETECTION OF SARS-COV-2 VERITOR (MATERIAL # 256082) FOR THE REPORTED BATCH NUMBER 1004994 (ACTUALLY KIT BATCH NUMBER, 1011283). 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 AND TESTING WERE PERFORMED ON THE BATCH NUMBER PROVIDED ONLY AND NO ISSUE WAS FOUND. THE COMPLAINT WAS UNABLE TO BE CONFIRMED VIA THE RETAIN SAMPLES. THE ROOT CAUSE COULD NOT BE IDENTIFIED. A TREND WAS IDENTIFIED FOR FALSE POSITIVE RESULTS. BASED ON THE TREND, A CORRECTIVE AND PREVENTIVE ACTION (CAPA) 1878253 WAS INITIATED. BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS. THERE WERE NO CORRECTIVE ACTIONS TAKEN AT THIS TIME. H3 OTHER TEXT: SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING FOR SARS COV-2 2 FALSE POSITIVE RESULTS WERE OBTAINED. REPEAT TESTS WERE PERFORMED USING PCR AND THE RESULTS WERE NEGATIVE. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. EUA#: EUA (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " MD AT BD, CONTACTED ME TO REPORT TWO DISCREPANCIES IN RESULTS BETWEEN BD VERITOR AND RT-PCR IN TWO ASYMPTOMATIC BD ASSOCIATES AT THE CURITIBA PLANT. THE FIRST ASSOCIATE (MHC) HAD A NASAL SWAB SAMPLE WITH A LITTLE BLOOD, DIFFERENT FROM THE SECOND ASSOCIATE (LW) WHO HAD A BLOODLESS NASAL SWAB SAMPLE. AFTER TAKING THE BD VERITOR OF BOTH MEMBERS, THEY WERE POSITIVE FOR SARS-COV-2. DR. REFERRED THE ASSOCIATES TO PERFORM RT-PCR THROUGH THE AGREEMENT AFTER 24 HOURS, WHERE BOTH RESULTS WERE NEGATIVE (TESTS PERFORMED THROUGH THE HEALTH PLAN)."

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE NUMBER: (B)(6). INITIAL REPORTER ADDRESS: (B)(6). MEDICAL 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.

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE TESTING FOR SARS COV-2 2 FALSE POSITIVE RESULTS WERE OBTAINED. REPEAT TESTS WERE PERFORMED USING PCR AND THE RESULTS WERE NEGATIVE. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. EUA#: (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " MD AT BD, CONTACTED ME TO REPORT TWO DISCREPANCIES IN RESULTS BETWEEN BD VERITOR AND RT-PCR IN TWO ASYMPTOMATIC BD ASSOCIATES AT THE (B)(6) PLANT. THE FIRST ASSOCIATE (B)(6) HAD A NASAL SWAB SAMPLE WITH A LITTLE BLOOD, DIFFERENT FROM THE SECOND ASSOCIATE (B)(6) WHO HAD A BLOODLESS NASAL SWAB SAMPLE. AFTER TAKING THE BD VERITOR OF BOTH MEMBERS, THEY WERE POSITIVE FOR SARS-COV-2. DR. REFERRED THE ASSOCIATES TO PERFORM RT-PCR THROUGH THE AGREEMENT AFTER 24 HOURS, WHERE BOTH RESULTS WERE NEGATIVE (TESTS PERFORMED THROUGH THE HEALTH PLAN)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660250 BD RAPID DETECTION OF SARS-COV-2 VERITOR CORONAVIRUS ANTIGEN DETECTION SYSTEM QKP BECTON, DICKINSON & CO. (SPARKS) 1004994

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown