BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAX¿ VAGINAL PANEL

    MDR report key: 23707092 · Received December 3, 2025

    Report

    Report Number
    3007420875-2025-00226
    Event Type
    Malfunction
    Date Received
    December 3, 2025
    Date of Event
    November 7, 2025
    Report Date
    February 17, 2026
    Manufacturer
    GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)
    Product Code
    PCH
    UDI-DI
    00382904437121
    PMA / PMN Number
    K201017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WHEN USING THE BD MAX¿ VAGINAL PANEL (REF. (B)(4)) LOT 5050864 WAS PERFORMED BY THE REVIEW OF MANUFACTURING RECORDS, RETAIN MATERIAL TESTING AND BY THE COMPLAINT¿S HISTORY REVIEW. THE CUSTOMER REPORTED TWO SUSPECTED FALSE NEGATIVE RESULTS ON BD MAX¿ VAGINAL PANEL (REF # (B)(4) KIT LOT 5050864. ACCORDING TO CUSTOMER, BOTH SAMPLES WERE NEGATIVE FOR THE TRICHOMONAS VAGINALIS TARGET (TV) AND POSITIVE FOR THE SAME TARGET ON KIT BD MAX¿ CTGCTV2 PANEL (REF # (B)(4), WITH EACH SAMPLE TESTED TWICE ON BOTH ASSAYS. CUSTOMER WAS EXPECTING THE SAME RESULT FOR THE TV TARGET WITH BOTH ASSAYS. THE REVIEW OF QUALITY CONTROL RECORDS OF BD MAX¿ VAGINAL PANEL LOT 5050864 REVEALED NO ANOMALIES THAT COULD EXPLAIN THE CUSTOMER¿S DISCREPANT RESULT. THE RETAIN MATERIAL OF BD MAX¿ VAGINAL PANEL FROM LOT 5050864 WAS TESTED AND THE RESULTS WERE AS EXPECTED. ASIDE FROM THE INFORMATION AVAILABLE IN THE COMPLAINT TEXT, NO ADDITIONAL DATA WAS AVAILABLE FOR INVESTIGATION. WITHOUT DATA NO ANALYSIS WAS POSSIBLE. IT MUST BE NOTED THAT LOD CAN VARY BETWEEN DIFFERENT ASSAYS, INCLUDING THE TV TARGET. MOREOVER, THE CONCENTRATION OF TARGET DNA CAN DIFFER BETWEEN DIFFERENT SPECIMENS COLLECTED FROM THE SAME PATIENT. FURTHERMORE, ACCORDING TO THE PACKAGE INSERTS FOR BOTH THE BD MAX¿ VAGINAL PANEL ASSAY AND THE BD CTGC/TV2 ASSAY FOR THE BD MAX¿ SYSTEM, A REPEAT SHOULD ONLY BE DONE WHEN THE RESULT IS IND, INC, OR UNR (FOR ONE OR MORE TARGETS). THERE IS NO INDICATION OF A REAGENT ISSUE BASED ON THE ANALYSIS OF THE COMPLAINTS RECEIVED FOR DISCREPANT RESULTS ON BD MAX¿ VAGINAL PANEL LOT 5050864. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. BD DID NOT INITIATE A CORRECTIVE AND A PREVENTIVE ACTION PLAN SINCE NO NEW HAZARD OR TRENDS WAS IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF BD MAX¿ VAGINAL PANEL, A FALSE NEGATIVE TRICHOMONAS VAGINALIS (TV) PATIENT RESULT WAS OBTAINED. SAMPLE TESTED TV POSITIVE ON BD MAX¿ CTGCTV2 ON 2 DIFFERENT BD MAX INSTRUMENTS, AND TV NEGATIVE ON 2 DIFFERENT BD MAX INSTRUMENTS ON BD MAX¿ VAGINAL PANEL. THERE WAS NO REPORT OF PATIENT IMPACT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF BD MAX¿ VAGINAL PANEL, A FALSE NEGATIVE TRICHOMONAS VAGINALIS (TV) PATIENT RESULT WAS OBTAINED. SAMPLE TESTED TV POSITIVE ON BD MAX¿ CTGCTV2 ON 2 DIFFERENT BD MAX INSTRUMENTS, AND TV NEGATIVE ON 2 DIFFERENT BD MAX INSTRUMENTS ON BD MAX¿ VAGINAL PANEL. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2844574 BD MAX¿ VAGINAL PANEL VAGINITIS AND BACTERIAL VAGINOSIS NUCLEIC ACID DETECTION SYSTEM PCH GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) 5050864 00382904437121

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown