BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD RESPIRATORY VIRAL PANEL FOR BD MAX¿ SYSTEM

    MDR report key: 16854234 · Received May 2, 2023

    Report

    Report Number
    3007420875-2023-00046
    Event Type
    Malfunction
    Date Received
    May 2, 2023
    Date of Event
    April 6, 2023
    Report Date
    May 25, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    GQG
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY THE COMPLAINT INVESTIGATION FOR WEAK MIRRORED CURVES WHEN USING THE BD RESPIRATORY VIRAL PANEL FOR BD MAX¿ SYSTEM (REF. (B)(4) LOT: 2229195 WAS PERFORMED BY THE REVIEW OF MANUFACTURING RECORDS, RETAIN MATERIAL TESTING, CUSTOMER¿S DATA ANALYSIS AND VERIFICATION OF COMPLAINTS HISTORY. REVIEW OF THE MANUFACTURING RECORDS OF BD RESPIRATORY VIRAL PANEL FOR BD MAX¿ SYSTEM INDICATED THAT LOT: 2229195 WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. THE RETAIN MATERIAL OF BD RESPIRATORY VIRAL PANEL KIT FOR BD MAX¿ SYSTEM FROM LOT: 2229195 WAS TESTED AND ALL RESULTS WERE AS EXPECTED. CUSTOMER OBSERVED WEAK MIRRORED CURVES IN THE 530/565NM (VIC) CHANNEL, WHICH DETECTS THE RESPIRATORY SYNCYTIAL VIRUS (RSV) TARGET, WHEN A STRONG COV2 TARGET (475/520NM (FAM) CHANNEL) AMPLIFICATION IS PRESENT, WHEN USING THE BD RESPIRATORY VIRAL PANEL FOR BD MAX¿ SYSTEM. CUSTOMER PROVIDED RUNS 2259 AND 2260 (PDF FILES ONLY) FROM INSTRUMENT CT1086 FOR INVESTIGATION. BASED ON ANALYSIS, SAMPLES A10 (RUN 2259) AND A1 (RUN 2260) WERE IDENTIFIED AS THE CONCERNED SAMPLES. THE MANUAL PCR CURVES ANALYSIS REVEALED, AS DESCRIBED BY THE CUSTOMER, THAT WHEN A STRONG COV2 TARGET (475/520NM (FAM) CHANNEL) AMPLIFICATION IS PRESENT, A WEAK MIRRORED CURVES IN THE 530/565NM (VIC) CHANNEL IS OBSERVED. HOWEVER, THE DOWNWARD CURVE OBSERVED IN THE VIC CHANNEL IS NOT UNUSUAL. IT IS AN ARTEFACT LINKED TO THE ASSAY DESIGN, WITHOUT CONSEQUENCE ON RSV DETECTION. DATA FROM THE MIXED INFECTION/COMPETITIVE INTERFERENCE STUDY PRESENTED IN THE ASSAY PACKAGE INSERT (P0261, TABLE 11), REVEALED THAT FOR THE TWENTY SAMPLES CO-INFECTED WITH HIGH LOAD OF COV-2 ANALYTES, ALL GAVE EXPECTED POSITIVE RSV RESULTS. THERE IS NO ISSUE WITH RSV DETECTION IN PRESENCE OF SARS-COV2 TARGET. BASED ON THE INVESTIGATION AND CUSTOMER DATA ANALYSIS, NO FALSE NEGATIVE RESULT WAS OBTAINED, AND THE ASSAY PERFORMED AS EXPECTED. THERE IS NO INDICATION OF A REAGENT ISSUE BASED ON THE ANALYSIS OF THE COMPLAINTS RECEIVED FOR UNUSUAL CURVES ON BD RESPIRATORY VIRAL PANEL FOR BD MAX¿ SYSTEM LOT: 2229195. THE ROOT CAUSE WAS NOT IDENTIFIED SINCE NO REAGENT ISSUE WAS IDENTIFIED. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. NO CORRECTIVE AND PREVENTIVE ACTION (CAPA) WAS INITIATED AT THIS TIME SINCE NO NEW HAZARD WAS IDENTIFIED. BD APOLOGIZES FOR THE INCONVENIENCE THAT THIS MAY HAVE CAUSED. BD LIFE SCIENCES QUALITY WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD RESPIRATORY VIRAL PANEL FOR BD MAX¿ SYSTEM RSV CHANNELS ARE NEGATIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CURVES FOR THE RSV CHANNELS ARE NEGATIVE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD RESPIRATORY VIRAL PANEL FOR BD MAX¿ SYSTEM RSV CHANNELS ARE NEGATIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CURVES FOR THE RSV CHANNELS ARE NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161486 BD RESPIRATORY VIRAL PANEL FOR BD MAX¿ SYSTEM N/A GQG BECTON, DICKINSON & CO. (SPARKS) 2229195

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown