BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAX¿ RESPIRATORY VIRAL PANEL

    MDR report key: 23831875 · Received December 17, 2025

    Report

    Report Number
    3007420875-2025-00268
    Event Type
    Malfunction
    Date Received
    December 17, 2025
    Date of Event
    November 30, 2025
    Report Date
    February 4, 2026
    Manufacturer
    GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)
    Product Code
    OOI
    UDI-DI
    00382904452155
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WITH THE BD RESPIRATORY VIRAL PANEL FOR BD MAX¿ SYSTEM (REF. (B)(4) LOT 5142531 WAS PERFORMED BY THE REVIEW OF THE MANUFACTURING RECORDS, CUSTOMER¿S DATA ANALYSIS AND VERIFICATION OF COMPLAINTS HISTORY. THE REVIEW OF QUALITY CONTROL RECORDS OF BD RESPIRATORY VIRAL PANEL FOR BD MAX¿ SYSTEM LOT 5142531 REVEALED NO ANOMALIES THAT COULD EXPLAIN THE CUSTOMER¿S DISCREPANT RESULTS. THE CUSTOMER REPORTED A LATE CT WITHOUT TRUE AMPLIFICATION AND OBSERVED A MIRRORED CURVE IN THE VIC CHANNEL WHEN AMPLIFICATION OCCURRED IN THE FAM CHANNEL. CUSTOMER PROVIDED RUN 5249 FROM THE BD MAX¿ INSTRUMENT CT0689 FOR INVESTIGATION AND SAMPLE IN POSITION B3 WAS IDENTIFIED BY THE CUSTOMER AS THE AFFECTED SAMPLE. MANUAL PCR CURVE ADJUDICATION WAS PERFORMED IN THE FAM CHANNEL (COV2 TARGET) AND REVEALED LATE AND LOW AMPLIFICATION FOR SAMPLE B3. LOW POSITIVE SAMPLES CAN OCCUR DUE TO VIRAL TITTERS IN THE SPECIMEN BEING AT OR NEAR THE LIMIT OF DETECTION OF THE ASSAY OR THROUGH ENVIRONMENTAL OR CROSS CONTAMINATION INTRODUCED DURING THE SAMPLE PREPARATION AT THE CUSTOMER¿S SITE. CONSIDERING A POSITIVE SAMPLE WITH EARLY CT (CT=15.66) WAS PRESENT IN THE SAME RUN (SAMPLE B5), THE LATTER IS SUSPECTED OF BEING LINKED TO THE CUSTOMER POSITIVE RESULT. CUSTOMER ALSO QUESTIONED THE MIRRORED NEGATIVE CURVES FOR THE RSV TARGET (VIC CHANNEL) ASSOCIATED WITH POSITIVE RESULTS FOR THE SARS-COV-2 TARGET (FAM CHANNEL) WHEN USING THE BD RESPIRATORY VIRAL PANEL FOR BD MAX¿ SYSTEM KIT LOT 5142531. AS DESCRIBED BY THE CUSTOMER, CURVES ANALYSIS REVEALED A COV2 TARGET AMPLIFICATION IN THE FAM CHANNEL FOR SAMPLE B5, AND A MIRRORED CURVE IN THE VIC CHANNEL. 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, 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. THERE IS NO INDICATION OF A REAGENT ISSUE BASED ON THE ANALYSIS OF THE COMPLAINTS RECEIVED FOR DISCREPANT RESULTS ON BD RESPIRATORY VIRAL PANEL FOR BD MAX¿ SYSTEM LOT 5142531. THE ROOT CAUSE WAS NOT IDENTIFIED. HOWEVER, POSITIVE SAMPLE AT OR NEAR THE ASSAY LIMIT OF DETECTION (LOD) OR AN ENVIRONMENTAL OR CROSS CONTAMINATION AT THE CUSTOMER¿S SITE ARE THE MOST LIKELY CAUSE TO EXPLAIN THE CUSTOMER¿S DISCREPANT RESULTS. 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.

    Additional Manufacturer Narrative · 0

    D.2. ADDITIONAL MEDICAL DEVICE TYPES: NJR E.1. INITIAL REPORTER PHONE NUMBER: (B)(6). E.1. INITIAL REPORTER FAX NUMBER: (B)(6). 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 THAT DURING USE OF BD MAX¿ RESPIRATORY VIRAL PANEL, A FALSE POSITIVE SARS-COV-2 PATIENT RESULT WITH WEAK PCR CURVE WAS OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF BD MAX¿ RESPIRATORY VIRAL PANEL, A FALSE POSITIVE SARS-COV-2 PATIENT RESULT WITH WEAK PCR CURVE WAS OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2182559 BD MAX¿ RESPIRATORY VIRAL PANEL MULTIPLE-GENUS RESPIRATORY VIRUS NUCLEIC ACID IVD KIT OOI GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) 5142531 00382904452155

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown