BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VERITOR¿ SARS-COV-2 AND FLU A+B

    MDR report key: 12579996 · Received October 5, 2021

    Report

    Report Number
    3006948883-2021-00955
    Event Type
    Malfunction
    Date Received
    October 5, 2021
    Date of Event
    September 8, 2021
    Report Date
    December 23, 2021
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    Product Code
    QMN
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 FALSE POSITIVE RESULTS WHEN USING KIT BD VERITOR¿ SARS-COV-2 AND FLU A+B (MATERIAL # 256088), BATCH NUMBER 1189936. 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. THE REPORTED WAS UNABLE TO BE CONFIRMED. THE ROOT CAUSE COULD NOT BE IDENTIFIED. BD QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    CORRECTION: THE FOLLOWING FIELDS WERE ENTERED INCORRECTLY AND HAVE BEEN UPDATED: D.2. COMMON DEVICE NAME: NOT CLASSIFIED. D.2. MEDICAL DEVICE TYPE: QMN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD VERITOR¿ SARS-COV-2 AND FLU A+B PRODUCED A FALSE POSITIVE RESULT. PCR TESTING WAS USED TO CONFIRM THAT THE RESULT WAS DISCREPANT, AND THE ERRONEOUS RESULT WAS NOT REPORTED TO CLINICIANS. THERE WAS NO REPORT OF ADVERSE PATIENT IMPACT. THIS COMPLAINT WAS CREATED TO CAPTURE THE 3RD OF 3 RELATED INCIDENTS. EUA#: (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER IS CLAIMING 3 FALSE POSITIVE RESULTS. ASYMPTOMATIC PATIENTS PRE OP AGES: 19 YEARS OLD, 70 YEARS OLD AND 79 YEARS OLD. PCR TEST AS CONFIRMATORY TEST." "WERE ANY ERRONEOUS RESULTS REPORTED TO THE DOCTORS? NO. IF YES, WERE ANY PATIENTS TREATED BASED ON ERRONEOUS RESULTS? N/A. IF YES, DID THE ERRONEOUS TREATMENT HAVE ANY ADVERSE IMPACT TO THE PATIENT(S)? N/A."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD VERITOR¿ SARS-COV-2 AND FLU A+B PRODUCED A FALSE POSITIVE RESULT. PCR TESTING WAS USED TO CONFIRM THAT THE RESULT WAS DISCREPANT, AND THE ERRONEOUS RESULT WAS NOT REPORTED TO CLINICIANS. THERE WAS NO REPORT OF ADVERSE PATIENT IMPACT. THIS COMPLAINT WAS CREATED TO CAPTURE THE 3RD OF 3 RELATED INCIDENTS. EUA#: (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER IS CLAIMING 3 FALSE POSITIVE RESULTS. ASYMPTOMATIC PATIENTS PRE OP AGES: 19 YEARS OLD, 70 YEARS OLD AND 79 YEARS OLD. PCR TEST AS CONFIRMATORY TEST." "WERE ANY ERRONEOUS RESULTS REPORTED TO THE DOCTORS? NO. IF YES, WERE ANY PATIENTS TREATED BASED ON ERRONEOUS RESULTS? N/A. IF YES, DID THE ERRONEOUS TREATMENT HAVE ANY ADVERSE IMPACT TO THE PATIENT(S)? N/A".

    Additional Manufacturer Narrative · 1

    DATE OF BIRTH: UNKNOWN. THE PATIENT¿S AGE WAS USED TO DETERMINE A PLACEHOLDER DATE FOR THIS FIELD. 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 VERITOR¿ SARS-COV-2 AND FLU A+B PRODUCED A FALSE POSITIVE RESULT. PCR TESTING WAS USED TO CONFIRM THAT THE RESULT WAS DISCREPANT, AND THE ERRONEOUS RESULT WAS NOT REPORTED TO CLINICIANS. THERE WAS NO REPORT OF ADVERSE PATIENT IMPACT. THIS COMPLAINT WAS CREATED TO CAPTURE THE 3RD OF 3 RELATED INCIDENTS. EUA#:(B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER IS CLAIMING 3 FALSE POSITIVE RESULTS. ASYMPTOMATIC PATIENTS PRE OP AGES: (B)(6) OLD, (B)(6) OLD AND (B)(6) OLD. PCR TEST AS CONFIRMATORY TEST." "WERE ANY ERRONEOUS RESULTS REPORTED TO THE DOCTORS? NO. IF YES, WERE ANY PATIENTS TREATED BASED ON ERRONEOUS RESULTS? N/A. IF YES, DID THE ERRONEOUS TREATMENT HAVE ANY ADVERSE IMPACT TO THE PATIENT(S)? N/A".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1473650 BD VERITOR¿ SARS-COV-2 AND FLU A+B NOT CLASSIFIED QMN BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 1189936
    1473651 BD VERITOR¿ SARS-COV-2 AND FLU A+B NOT CLASSIFIED QMN BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 1189936

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Unknown