BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD RAPID DETECTION OF SARS-COV-2 VERITOR

    MDR report key: 12509866 · Received September 21, 2021

    Report

    Report Number
    3006948883-2021-00939
    Event Type
    Malfunction
    Date Received
    September 21, 2021
    Date of Event
    July 26, 2021
    Report Date
    October 20, 2021
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    Product Code
    QKP
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 2021-09-30. INVESTIGATION SUMMARY: THIS STATEMENT SUMMARIZES THE INVESTIGATION RESULTS REGARDING THE COMPLAINTS THAT ALLEGES FALSE NEGATIVE OR DISCREPANT RESULTS WHEN USING KIT BD VERITOR FOR RAPID DETECTION OF SARS-COV-2 CE (MATERIAL # 256089), BATCH NUMBER 1020841. BD QUALITY PERFORMS A SYSTEMATIC APPROACH TO INVESTIGATE FALSE NEGATIVE COMPLAINTS. THIS APPROACH INVOLVES REVIEW OF MANUFACTURING BATCH HISTORY RECORDS, TESTING OF RETENTION SAMPLES, AND TESTING OF CUSTOMER RETURNED SAMPLES IF APPLICABLE. INVESTIGATION AND TESTING WERE PERFORMED ON THE BATCH NUMBERS PROVIDED. THE COMPLAINT WAS UNABLE TO BE CONFIRMED. THE COMPLAINT SAMPLE WAS RETURNED TO BD AS NOTED IN TRACKING NUMBER DHL 4426268641 AND DHL 6225718166. THE RETURNED PRODUCT WAS RECEIVED ON 9/30/2021 AND 10/5/21. THE PRODUCT EXPIRED ON 6/22/2021. BD MAKES NO CLAIMS ON EXPIRED PRODUCTS AND STABILITY STUDIES HAVE SHOWN THE USE OF EXPIRED MATERIALS MAY AFFECT THE SENSITIVITY OF THE ASSAY. THEREFORE, RETURNED MATERIALS PAST THE EXPIRY WILL NOT BE TESTED. 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 THAT THE BD RAPID DETECTION OF SARS-COV-2 VERITOR WHILE TESTING FOR SARS COV-2 RECEIVED A FALSE NEGATIVE RESULT DURING ART AND PCR TESTING. THERE WAS NO REPORT OF SERIOUS INJURY OR MEDICAL INTERVENTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: EUA#: (B)(4). RECEIVED FEEDBACK OVER EFFECTIVENESS OF ART TESTING IN GENERAL. A SPECIAL OPS STARTED STARTING 15 JULY TO SCREEN 100 TRUCKERS (NON VACCINATED) PER DAY FOR ART & PCR WAS CONDUCTED. THEY HAVE SEEN AN INCREASE IN THE NUMBER OF FALSE NEGATIVES EVEN WITH LOW PCR CT VALUES IN RECENT WEEKS. THIS PERSISTED AFTER THEY CHANGED THE SWABBING TECHNIQUE TO NP AFTER OUR LAST CALL WITH THEM. FROM THEIR RECORD, OUR SENSITIVITY WAS 92-93%, AND HAVE DROPPED TO ~90%.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD RAPID DETECTION OF SARS-COV-2 VERITOR WHILE TESTING FOR SARS COV-2 RECEIVED A FALSE NEGATIVE RESULT DURING ART AND PCR TESTING. THERE WAS NO REPORT OF SERIOUS INJURY OR MEDICAL INTERVENTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: EUA#: (B)(4). RECEIVED FEEDBACK OVER EFFECTIVENESS OF ART TESTING IN GENERAL. A SPECIAL OPS STARTED STARTING (B)(6) TO SCREEN 100 TRUCKERS (NON VACCINATED) PER DAY FOR ART & PCR WAS CONDUCTED. THEY HAVE SEEN AN INCREASE IN THE NUMBER OF FALSE NEGATIVES EVEN WITH LOW PCR CT VALUES IN RECENT WEEKS. THIS PERSISTED AFTER THEY CHANGED THE SWABBING TECHNIQUE TO NP AFTER OUR LAST CALL WITH THEM. FROM THEIR RECORD, OUR SENSITIVITY WAS 92-93%, AND HAVE DROPPED TO 90%.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1406641 BD RAPID DETECTION OF SARS-COV-2 VERITOR CORONAVIRUS ANTIGEN DETECTION SYSTEM QKP BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 1020841

    Patients

    Seq Age Sex Outcome Treatment
    1 Male