BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VERITOR ¿ SARS-COV-2 & FLU A+B

    MDR report key: 18583813 · Received January 25, 2024

    Report

    Report Number
    3006948883-2024-00011
    Event Type
    Malfunction
    Date Received
    January 25, 2024
    Date of Event
    December 30, 2023
    Report Date
    June 18, 2024
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    Product Code
    QMN
    UDI-DI
    00382902580881
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THIS STATEMENT SUMMARIZES THE INVESTIGATION RESULTS REGARDING A COMPLAINT THAT ALLEGES INVALID RESULT (MULTIPLE LINES), FALSE POSITIVE AND DISCREPANT RESULT WHEN USING BD VERITOR¿ SARS-COV-2 AND FLU A+B ASS (MATERIAL#: 256088), BATCH NUMBER 3240177. THE CUSTOMER REPORTED SEEING ADDITIONAL LINES ON THE TEST DEVICES WHEN TESTED FOUR SYMPTOMATIC PATIENTS. THEY SUBMITTED THE SAMPLES FOR CONFIRMATORY PCR TESTING AND RECEIVED DIFFERENT RESULTS FOR TWO PATIENTS. BD QUALITY PERFORMS A SYSTEMATIC APPROACH TO INVESTIGATE ALL COMPLAINTS. THIS APPROACH INVOLVES REVIEW OF MANUFACTURING BATCH HISTORY RECORDS, VISUAL INSPECTION OF RETENTION SAMPLES, AND VISUAL INSPECTION OF CUSTOMER RETURNED SAMPLES, IF APPLICABLE. BATCH HISTORY RECORD (BHR) REVIEW AND RETAIN SAMPLE TESTING WERE PERFORMED ON THE BATCH NUMBER PROVIDED. THE RESULTS WERE ACCEPTABLE, AND NO RELEVANT ISSUES WERE FOUND. NO PHOTOS OR SAMPLES WERE RECEIVED; THEREFORE, RETURN SAMPLE ANALYSIS COULD NOT BE PERFORMED. THE REPORTED ISSUE WAS UNABLE TO BE CONFIRMED. A TREND ANALYSIS FOR DISCREPANT RESULT, INVALID RESULT AND FALSE POSITIVE WAS CONDUCTED, NO ADVERSE TREND WAS IDENTIFIED. THERE WERE NO CORRECTIVE ACTIONS TAKEN AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH THE BD VERITOR ¿ SARS-COV-2 & FLU A+B ASSAY, DISCREPANT PATIENT RESULTS WERE OBTAINED. THE RESULT PROVIDED WAS COVID POSITIVE. CONFIRMATORY PCR TESTING GAVE THE RESULT OF FLU A POSITIVE. THERE WAS NO REPORT OF PATIENT IMPACT. EUA: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH THE BD VERITOR ¿ SARS-COV-2 & FLU A+B ASSAY, DISCREPANT PATIENT RESULTS WERE OBTAINED. THE RESULT PROVIDED WAS COVID POSITIVE. CONFIRMATORY PCR TESTING GAVE THE RESULT OF FLU A POSITIVE. THERE WAS NO REPORT OF PATIENT IMPACT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1120774 BD VERITOR ¿ SARS-COV-2 & FLU A+B NOT CLASSIFIED QMN BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 3240177 00382902580881

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown