BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 12530521 · Received September 24, 2021

    Report

    Report Number
    3006948883-2021-00946
    Event Type
    Malfunction
    Date Received
    September 24, 2021
    Date of Event
    August 23, 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
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY THIS STATEMENT SUMMARIZES THE INVESTIGATION RESULTS REGARDING THE COMPLAINT THAT ALLEGES 16 OUT OF 30 FALSE POSITIVE RESULTS WHEN USING KIT (RAPID DETECTION OF SARS-COV-2 & 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 AND NO RELEVANT ISSUE WAS FOUND. THE COMPLAINT WAS UNABLE TO BE CONFIRMED VIA THE RETAIN SAMPLES. THE ROOT CAUSE COULD NOT BE IDENTIFIED. A TREND ANALYSIS FOR FALSE POSITIVE RESULTS WAS CONDUCTED, NO ADVERSE TREND WAS IDENTIFIED. BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS. THERE WERE NO CORRECTIVE ACTIONS TAKEN AT THIS TIME. H3 OTHER TEXT : SEE H10

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED WITH CORRECTED INFORMATION: D2: PRODUCT CODE: QMN; COMMON DEVICE NAME: NOT CLASSIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD VERITOR¿ SARS-COV-2 AND FLU A+B 16 FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. EUA# 203152. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " HE GOT 16 FLU A POS RESULTS"

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD VERITOR¿ SARS-COV-2 AND FLU A+B 16 FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. 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: " HE GOT 16 FLU A POS RESULTS".

    Additional Manufacturer Narrative · 1

    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 THAT WHILE USING BD VERITOR¿ SARS-COV-2 AND FLU A+B 16 FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. 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: " HE GOT 16 FLU A POS RESULTS".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1427310 BD VERITOR¿ SARS-COV-2 AND FLU A+B NOT CLASSIFIED QMN BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 1189936
    1427311 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 Unknown