BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VERITOR ¿ SARS-COV-2 & FLU A+B

    MDR report key: 13529740 · Received February 14, 2022

    Report

    Report Number
    3006948883-2022-00021
    Event Type
    Malfunction
    Date Received
    February 14, 2022
    Date of Event
    January 21, 2022
    Report Date
    March 16, 2022
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    Product Code
    QMN
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY THIS STATEMENT IS TO SUMMARIZE THE INVESTIGATION RESULTS REGARDING YOUR COMPLAINT THAT ALLEGES ERRONEOUS RESULTS (INITIAL RESULT OF FLUA POSITIVE THEN COVID POSITIVE, THIRD TIME FLUB POSITIVE) WHEN USING BD VERITOR¿ SARS-COV-2 AND FLU A+B (MATERIAL # 256088), BATCH NUMBER 1252913. BD QUALITY PERFORMS A SYSTEMATIC APPROACH TO INVESTIGATE ERRONEOUS RESULTS 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. THE CUSTOMER ACKNOWLEDGED THAT THEY HAD ATTEMPTED TO READ RESULTS AFTER THE APPROPRIATE INCUBATION TIME PASSED. THE CUSTOMER DID NOT RECOLLECT THE PATIENT AND DID NOT CONFIRM THE ALLEGED ERRONEOUS RESULTS BY PCR. THE REPORTED ISSUE WAS UNABLE TO BE CONFIRMED. THE ROOT CAUSE COULD NOT BE IDENTIFIED. BD QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    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 · 0

    IT WAS REPORTED WHEN USING THE BD VERITOR ¿ SARS-COV-2 & FLU A+B THERE WERE DISCREPANT RESULTS. EUA# (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER EXPERIENCED ERRONEOUS RESULTS WITH THE TRIPLEX ASSAY. CUSTOMER CLAIM THAT ON 1 ASYMPTOMATIC PATIENTS THEY GOT AN INITIAL RESULT OF FLUA POSITIVE REST ARE NEGATIVE, THEY NOTICED NO LINE NEXT TO FLU A SO THEY INSERT THE TEST DEVICE GAVE COVID + REST ARE NEGATIVE, REINSERT 3RD TIME GAVE FLUB + REST ARE NEGATIVE. THEY INSERTED THE SAME TEST DEVICE ON ANOTHER VERITOR ANALYZER GAVE ALL NEGATIVE. CUSTOMER DIDN'T RUN QC ON THIS LOT NUMBER. IT WAS EXPLAINED THE TEST IS NOT VALIDATED TO BE READ BY EYE AND AS LONG AS VC AND QC PASS THEY NEED TO GO WITH THE ANALYZER RESULTS. ALL DIFFERENT ZONES FOUND IN THE TEST DEVICE AS WELL AS THE SPECIMEN MATRIX. CUSTOMER NEEDS TO STICK WITH THE VALIDATED INCUBATION TIME AND NOT TO READ THE RESULT BEYOND INCUBATION TIME BECAUSE THIS MAY GIVE FALSE RESULTS. CUSTOMER ACKNOWLEDGE THEIR MISTAKE. THEY WILL START RUNNING QC AND WILL NOT READ RESULTS AFTER INCUBATION TIME PASSED. CUSTOMER DIDN'T RECOLLECT THE PATIENT AND DIDN'T CONFIRM THE CLAIMED ERRONEOUS RESULTS BY PCR. CONFIRMATORY TESTING WAS NOT PERFORMED. THERE WAS NO REPORT OF PATIENT IMPACT.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VERITOR ¿ SARS-COV-2 & FLU A+B THERE WERE DISCREPANT RESULTS. EUA# (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER EXPERIENCED ERRONEOUS RESULTS WITH THE TRIPLEX ASSAY. CUSTOMER CLAIM THAT ON 1 ASYMPTOMATIC PATIENTS THEY GOT AN INITIAL RESULT OF FLUA POSITIVE REST ARE NEGATIVE, THEY NOTICED NO LINE NEXT TO FLU A SO THEY INSERT THE TEST DEVICE GAVE COVID + REST ARE NEGATIVE, REINSERT 3RD TIME GAVE FLUB + REST ARE NEGATIVE. THEY INSERTED THE SAME TEST DEVICE ON ANOTHER VERITOR ANALYZER GAVE ALL NEGATIVE. CUSTOMER DIDN'T RUN QC ON THIS LOT NUMBER. IT WAS EXPLAINED THE TEST IS NOT VALIDATED TO BE READ BY EYE AND AS LONG AS VC AND QC PASS THEY NEED TO GO WITH THE ANALYZER RESULTS. ALL DIFFERENT ZONES FOUND IN THE TEST DEVICE AS WELL AS THE SPECIMEN MATRIX. CUSTOMER NEEDS TO STICK WITH THE VALIDATED INCUBATION TIME AND NOT TO READ THE RESULT BEYOND INCUBATION TIME BECAUSE THIS MAY GIVE FALSE RESULTS. CUSTOMER ACKNOWLEDGE THEIR MISTAKE. THEY WILL START RUNNING QC AND WILL NOT READ RESULTS AFTER INCUBATION TIME PASSED. CUSTOMER DIDN'T RECOLLECT THE PATIENT AND DIDN'T CONFIRM THE CLAIMED ERRONEOUS RESULTS BY PCR. CONFIRMATORY TESTING WAS NOT PERFORMED. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1845490 BD VERITOR ¿ SARS-COV-2 & FLU A+B NOT CLASSIFIED QMN BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 1252913

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown