BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD RAPID DETECTION OF SARS-COV-2 VERITOR

    MDR report key: 11917013 · Received June 1, 2021

    Report

    Report Number
    3006948883-2021-00634
    Event Type
    Malfunction
    Date Received
    June 1, 2021
    Date of Event
    May 7, 2021
    Report Date
    December 9, 2021
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    Product Code
    QKP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: THIS STATEMENT IS TO SUMMARIZE THE INVESTIGATION RESULTS REGARDING THE COMPLAINTS THAT ALLEGES FALSE NEGATIVE RESULTS WHEN USING KIT BD VERITOR FOR RAPID DETECTION OF SARS-COV-2 VERITOR CE (MN# 256089), BATCH NUMBER 1021484. 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. A BATCH REVIEW WAS PERFORMED FOR THE NUMBER PROVIDED. THE REPORTED ISSUE WAS UNABLE TO BE CONFIRMED. THE RETENTION TESTING COULD NOT BE TESTED AS THEY ARE EXPIRED. RETURNED PRODUCT TESTING COULD NOT BE COMPLETED A SAMPLES ARE EXPIRED. A PHOTOGRAPH WAS RETURNED AND SHOWED SARS-COV-2 VERITOR TEST RESULT AND IS UNABLE TO CONFIRM FALSE NEGATIVE. THERE ARE NO CURRENT TRENDS AGAINST FALSE NEGATIVE RESULTS. BD QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS.

    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 AND THE RESULT WAS 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: "IT WAS REPORTED THAT DISCREPANT RESULTS. WE ARE NOT REPORTING EITHER. WE UNDERSTAND THAT THE DEVICE SHOULD BE THE ONLY RESULT READ. HOWEVER, WE TESTED AN INDIVIDUAL WHO WAS POSITIVE ON THE LATERAL FLOW STRIP, AND NEGATIVE BY DEVICE. 12 HOURS LATER, POSITIVE ON THE STRIP AND DEVICE. WE UNDERSTAND THAT THIS WAS LIKELY AN EARLY INFECTION, AND THAT THERE WAS SIMPLY NOT ENOUGH VIRAL ANTIGEN IN THEIR NARES THE FIRST COLLECTION. WE ARE JUST INQUIRING WHETHER OTHER CUSTOMERS HAVE REPORTED SIMILAR. WAS THERE ANY PATIENT IMPACT AS A RESULT OF THE FALSE RESULT? SEE ABOVE - NOT NECESSARILY A FALSE RESULT. CUSTOMER PROBLEM: CUSTOMER REPORTS DISCREPANT RESULTS USING 256089 LOT 1021484 THEY REPORT THAT HAVE ONE TEST THAT THEY CAN SEE ON THE STRIP IS A POSITIVE RESULT, HOWEVER, WHEN THEY INSERT THE TEST INTO THE ANALYZER IT IS SHOWING NEGATIVE. BEFORE THAT THEY PERFORM ANOTHER TEST AND IT WAS NEGATIVE. "

    Additional Manufacturer Narrative · 1

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

    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 AND THE RESULT WAS 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: " IT WAS REPORTED THAT DISCREPANT RESULTS. WE ARE NOT REPORTING EITHER. WE UNDERSTAND THAT THE DEVICE SHOULD BE THE ONLY RESULT READ. HOWEVER, WE TESTED AN INDIVIDUAL WHO WAS POSITIVE ON THE LATERAL FLOW STRIP, AND NEGATIVE BY DEVICE. 12 HOURS LATER, POSITIVE ON THE STRIP AND DEVICE. WE UNDERSTAND THAT THIS WAS LIKELY AN EARLY INFECTION, AND THAT THERE WAS SIMPLY NOT ENOUGH VIRAL ANTIGEN IN THEIR NARES THE FIRST COLLECTION. WE ARE JUST INQUIRING WHETHER OTHER CUSTOMERS HAVE REPORTED SIMILAR. WAS THERE ANY PATIENT IMPACT AS A RESULT OF THE FALSE RESULT? SEE ABOVE - NOT NECESSARILY A FALSE RESULT. CUSTOMER PROBLEM: CUSTOMER REPORTS DISCREPANT RESULTS USING 256089 LOT 1021484 THEY REPORT THAT HAVE ONE TEST THAT THEY CAN SEE ON THE STRIP IS A POSITIVE RESULT, HOWEVER, WHEN THEY INSERT THE TEST INTO THE ANALYZER IT IS SHOWING NEGATIVE. BEFORE THAT THEY PERFORM ANOTHER TEST AND IT WAS NEGATIVE. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812279 BD RAPID DETECTION OF SARS-COV-2 VERITOR CORONAVIRUS ANTIGEN DETECTION SYSTEM QKP BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 1021484

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown