BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VERITOR ¿ SARS-COV-2 & FLU A+B

    MDR report key: 19078850 · Received April 10, 2024

    Report

    Report Number
    3006948883-2024-00047
    Event Type
    Malfunction
    Date Received
    April 10, 2024
    Date of Event
    March 8, 2024
    Report Date
    July 9, 2024
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    Product Code
    QMN
    UDI-DI
    00382902580881
    PMA / PMN Number
    SEE H.10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G.5. EUA NUMBER: EUA (B)(4). 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

    H.6. INVESTIGATION SUMMARY: THIS STATEMENT SUMMARIZES THE INVESTIGATION RESULTS REGARDING A COMPLAINT THAT ALLEGES DISCREPANT RESULT WHEN USING BD VERITOR¿ SARS-COV-2 AND FLU A+B ASSAY (MATERIAL#: 256088), BATCH NUMBER 3240177. THE CUSTOMER REPORTED THAT THEY VISUALLY OBSERVED A LINE ON THE CARTRIDGE, BUT WHEN READ WITH THE ANALYZER, THE INITIAL RESULT IS POSITIVE. WHEN THEY REMOVE THE CARTRIDGE AND RE-INSERT 1-2 MINUTES LATER, THEY WOULD RECEIVE A NEGATIVE RESULT. 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 WERE RECEIVED. RETURN SAMPLES WERE NOT YET RECEIVED ON THE BATCH NUMBER PROVIDED BY BD QUALITY; THEREFORE, RETURN SAMPLE ANALYSIS COULD NOT BE PERFORMED. IF SAMPLES ARE RECEIVED AT A LATER DATE, THE COMPLAINT MAY BE REOPENED. THE REPORTED ISSUE WAS UNABLE TO BE CONFIRMED. A TREND ANALYSIS FOR DISCREPANT RESULT 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 WHILE USING THE BD VERITOR ¿ SARS-COV-2 & FLU A+B, THE USER VISUALLY INTERPRETED THE RESULT AND PERCEIVED THE RESULT AS DISCREPANT. THE USER SAW ONE (1) LINE ON THE CARTRIDGE AFTER INOCULATION, INSERTED THE CARTRIDGE INTO THE ANALYZER, WHICH READ IT AS POSITIVE, THEN REMOVED THE CARTRIDGE AND REINSERTED IT 1-2 MINUTES LATER, WHICH WAS THEN READ AS NEGATIVE BY THE ANALYZER. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. EUA (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD VERITOR ¿ SARS-COV-2 & FLU A+B, THE USER VISUALLY INTERPRETED THE RESULT AND PERCEIVED THE RESULT AS DISCREPANT. THE USER SAW ONE (1) LINE ON THE CARTRIDGE AFTER INOCULATION, INSERTED THE CARTRIDGE INTO THE ANALYZER, WHICH READ IT AS POSITIVE, THEN REMOVED THE CARTRIDGE AND REINSERTED IT 1-2 MINUTES LATER, WHICH WAS THEN READ AS NEGATIVE BY THE ANALYZER. NO HEALTH IMPACT OR CONSEQUENCE REPORTED. EUA (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121367 BD VERITOR ¿ SARS-COV-2 & FLU A+B CORONAVIRUS ANTIGEN DETECTION SYSTEM QMN BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 3240177 00382902580881

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown