BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF SARS-COV-2 & FLU A+B

    MDR report key: 20952508 · Received December 17, 2024

    Report

    Report Number
    3006948883-2024-00099
    Event Type
    Malfunction
    Date Received
    December 17, 2024
    Date of Event
    November 25, 2024
    Report Date
    March 11, 2025
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    Product Code
    QMN
    PMA / PMN Number
    SEE H.11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THIS STATEMENT SUMMARIZES THE INVESTIGATION RESULTS REGARDING A COMPLAINT THAT ALLEGES FALSE POSITIVE WHEN USING BD VERITOR¿ SARS-COV-2 AND FLU A+B ASS (MATERIAL#: 256088), BATCH NUMBER 4190377. THE CUSTOMER REPORTED THAT THEY ARE SEEING A HIGHER RATE OF FLU B. 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 BHR REVIEW RESULTS WERE ACCEPTABLE, AND NO RELEVANT ISSUES WERE FOUND. HOWEVER, THE RETAIN SAMPLE TESTING RESULTED IN ONE DEVICE WITH A FLU B FALSE POSITIVE USING RV REAGENT D DUE TO A SCRATCH BELOW THE FLU B LINE POSITION. ADDITIONALLY, ANOTHER DEVICE RESULTED IN A TEST INVALID (FLU A POSITIVE AND FLU B POSITIVE) USING THE FLU B NEGATIVE CONTROL SWAB. NO PHOTOS OR SAMPLES WERE RECEIVED; THEREFORE, RETURN SAMPLE ANALYSIS COULD NOT BE PERFORMED. THE REPORTED ISSUE WAS CONFIRMED THROUGH RETAIN TESTING. THE ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME. A TREND ANALYSIS FOR FALSE POSITIVE WAS CONDUCTED, NO ADVERSE TREND WAS IDENTIFIED. THERE WERE NO CORRECTIVE ACTIONS TAKEN AT THIS TIME. IF YOU HAVE ANY ADDITIONAL QUESTIONS OR CONCERNS, PLEASE DO NOT HESITATE TO CONTACT BD TECHNICAL SERVICES.

    Additional Manufacturer Narrative · 0

    B3. DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THE INFORMATION FOR THE 510K IS AS FOLLOWS: G4. PMA/510(K)#: EUA# (B)(4). 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¿ SYSTEM FOR RAPID DETECTION OF SARS-COV-2 AND FLU A+B, THE CUSTOMER QUESTIONED AN UNSPECIFIED NUMBER OF PATIENT FLU B POSITIVE RESULTS DUE TO THE HIGH NUMBER OBTAINED FROM THE VERITOR ANALYZER. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED. EUA# (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF SARS-COV-2 AND FLU A+B, THE CUSTOMER QUESTIONED AN UNSPECIFIED NUMBER OF PATIENT FLU B POSITIVE RESULTS DUE TO THE HIGH NUMBER OBTAINED FROM THE VERITOR ANALYZER. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED. EUA# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267304 BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF SARS-COV-2 & FLU A+B ANTIGEN DETECTION REAGENT KIT QMN BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 4190377

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown