BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM

    MDR report key: 21436548 · Received February 21, 2025

    Report

    Report Number
    3007420875-2025-00041
    Event Type
    Malfunction
    Date Received
    February 21, 2025
    Date of Event
    January 23, 2025
    Report Date
    May 23, 2025
    Manufacturer
    GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)
    Product Code
    QJR
    UDI-DI
    60382904450030
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WHEN USING THE BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM KIT (REF. 44500301) LOT 4233942 WAS PERFORMED BY THE REVIEW OF MANUFACTURING RECORDS, RETAIN MATERIAL TESTING, REVIEW OF CUSTOMER¿S DATA AND VERIFICATION OF COMPLAINTS HISTORY. REVIEW OF THE MANUFACTURING RECORDS OF THE BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM KIT INDICATED THAT LOT 4233942 WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. THE RETAIN MATERIAL OF BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM KIT FROM LOT 4233942 WAS TESTED AND THE RESULTS WERE AS EXPECTED. CUSTOMER COMPLAINED ABOUT A COVID NEGATIVE RESULT WHEN USING THE BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM KIT LOT 4233942 WHICH TESTED COV2 POSITIVE WHEN THE SAMPLE WAS RETESTED WITH THE BD RESPIRATORY VIRAL PANEL FOR BD MAX¿ SYSTEM ASSAY. CUSTOMER PROVIDED THE DATABASE FROM BD MAX¿ INSTRUMENT CT3385 FOR THE INVESTIGATION. THE SAMPLE WAS INITIALLY TESTED WITH THE BD SARS COV-2 REAGENTS FOR BD MAX¿ SYSTEMS KIT LOT 4233942 IN RUN 556 (POSITION A11) AND GAVE COV-2, N1 AND N2 NEGATIVE RESULTS. THE PATIENT SAMPLE WAS RETESTED USING THE BD RESPIRATORY VIRAL PANEL FOR BD MAX¿ SYSTEM ASSAY IN RUN 557 (POSITION A2) AND GAVE A COV-2 POSITIVE RESULT. MANUAL PCR CURVE ADJUDICATION OF THE COV-2 TARGETS IN THE DISCREPANT SAMPLES REVEALED A LATE AND LOW, BUT TRUE AMPLIFICATION, GENERATED A POSITIVE RESULT FOR THE COV2 TARGET WITH THE BD RESPIRATORY VIRAL PANEL FOR BD MAX¿ SYSTEM ASSAY (RUN 557), WITHOUT ANY ANOMALY. MOREOVER, NO ANOMALY WAS OBSERVED IN THE INITIAL TEST DONE WITH THE BD SARS COV-2 REAGENTS FOR BD MAX¿ SYSTEM ASSAY (RUN 556), WITH FLAT CURVES AND NO AMPLIFICATION OF ANY TARGET RESULTING IN THE COV2, N1 AND N2 NEGATIVE TARGETS. NEVERTHELESS, MANUAL CURVE ADJUDICATION HAS LIMITATIONS; VISUAL EXAMINATION OF PCR CURVES FOR LOW SIGNAL IS A CONSERVATIVE ASSESSMENT OF THE DATA. THERE IS NO INDICATION OF A REAGENT ISSUE BASED ON THE ANALYSIS OF THE COMPLAINTS RECEIVED FOR DISCREPANT RESULTS ON BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM KIT LOT 4233942. THE ROOT CAUSE WAS NOT IDENTIFIED. HOWEVER, A SPECIMEN AT OR NEAR THE ASSAY LIMIT OF DETECTION (LOD), OR ENVIRONMENTAL OR CROSS CONTAMINATION, ARE THE MOST LIKELY CAUSES TO EXPLAIN THE CUSTOMER¿S POSITIVE RESULTS IN THE REPEAT TEST WITH THE BD RESPIRATORY VIRAL PANEL FOR BD MAX¿ SYSTEM ASSAY. 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.

    Additional Manufacturer Narrative · 0

    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 THE BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM, A FALSE NEGATIVE SARS-COV-2 PATIENT RESULT WAS OBTAINED. SAMPLE WAS RETESTED USING BD RESPIRATORY VIRAL PANEL FOR BD MAX¿ SYSTEM AND WAS POSITIVE FOR SARS-COV-2. THERE WAS NO REPORT OF PATIENT IMPACT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM, A FALSE NEGATIVE SARS-COV-2 PATIENT RESULT WAS OBTAINED. SAMPLE WAS RETESTED USING BD RESPIRATORY VIRAL PANEL FOR BD MAX¿ SYSTEM AND WAS POSITIVE FOR SARS-COV-2. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1044288 BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM SARS-COV-2 VIRUS NUCLEIC ACID TECHNIQUE QJR GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) 4233942 60382904450030

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown