BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CTGCTV2 FOR BD MAX¿ SYSTEM

    MDR report key: 21815475 · Received April 10, 2025

    Report

    Report Number
    3007420875-2025-00060
    Event Type
    Malfunction
    Date Received
    April 10, 2025
    Date of Event
    February 17, 2025
    Report Date
    June 23, 2025
    Manufacturer
    GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)
    Product Code
    LSL
    PMA / PMN Number
    K210585
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D.2. ADDITIONAL MEDICAL DEVICE TYPES: MKZ, OUY, QEP. 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 BD COR¿ CTGCTV2 (REF. (B)(4) FROM LOTS 4150111 AND 4262606 WAS PERFORMED BY THE REVIEW OF MANUFACTURING RECORDS, REVIEW OF CUSTOMER¿S DATA AND BY THE COMPLAINT¿S HISTORY REVIEW. CUSTOMER COMPLAINED ABOUT THREE PATIENT SAMPLES, TWO OF WHICH GAVE DISCREPANT POSITIVE RESULTS FOR THE TRICHOMONAS VAGINALIS (TV) TARGET WITH KIT LOT 4150111 AND OBTAINED UNRESOLVED (UNR) RESULTS FOR THE CHLAMYDIA TRACHOMATIS (CT) AND NEISSERIA GONORRHOEAE (GC) TARGETS, ACCORDING TO THE CUSTOMER. THESE TWO SAMPLE WERE IDENTIFIED (B)(6). PER CUSTOMER PROCEDURES, THE SAMPLES WERE REPEATED ON THE BD MAX¿ INSTRUMENT AND OBTAINED NEGATIVE RESULTS FOR ALL THE TARGETS. THE THIRD SAMPLE GAVE SUSPECTED FALSE POSITIVE RESULTS FOR THE GC AND TV TARGETS WITH KIT LOTS 4262606 AND 4150111, AND ACCORDING TO THE CUSTOMER, OBTAINED AN UNRESOLVED (UNR) RESULT FOR THE CHLAMYDIA TRACHOMATIS (CT) TARGET, AND WAS NOT REPEATED. THIS SAMPLE WAS IDENTIFIED (B)(6). CUSTOMER QUESTIONED THE TV POSITIVE RESULTS FOR THESE THREE SAMPLES. CUSTOMER PROVIDED LOT NUMBERS FOR EACH OF THE KIT COMPONENTS, AND ALL WERE INVESTIGATED: FOR KIT LOT 4105111: EXTRACTION PLATE LOTS 4186480 AND 4192615, LIQUID REAGENT PLATE LOTS 4150111 AND MASTER MIX PLATE LOTS 4186463 AND 4192586; AND FOR KIT LOT 4262606: EXTRACTION PLATE LOT 4248345 AND LIQUID REAGENT PLATE LOT 4262606. REVIEW OF THE MANUFACTURING RECORDS OF THESE INDIVIDUAL COMPONENTS INDICATES THAT THOSE LOTS WERE MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER PROVIDED PRINT SCREENS OF BACKGROUND PCR CURVES FOR INVESTIGATION. PCR CURVES ANALYSIS FROM THE THREE PICTURES PROVIDED REVEALED STEP DISLOCATIONS IN THE CY5 CHANNEL (TV TARGET) FOR ALL THE SAMPLES. THESE ATYPICAL CURVES DO NOT SUGGEST TRUE AMPLIFICATION. IN THE ROX CHANNEL (INTERNAL CONTROL TARGET), THE SAME STEP DISLOCATIONS WERE VISIBLE AND DID NOT REACH THE THRESHOLD TO GIVE VALID RESULTS. THIS WOULD GENERATE UNR RESULTS FOR THE OTHER TARGETS, AND IT IS THUS POSSIBLE THAT UNR RESULTS WERE OBTAINED. HOWEVER, DESPITE MULTIPLE ATTEMPTS MADE TO RECEIVE ADDITIONAL DATA, NO ANALYSIS FOR THE OTHER TARGETS WAS POSSIBLE SINCE NO CSV FILES WAS PROVIDED. THE CAUSE OF THESE ATYPICAL CURVES COULD NOT BE INVESTIGATED FURTHER. ANALYSIS OF SAMPLE (B)(6) IN THE CY5.5 CHANNEL (GC2 TARGET) REVEALED THAT EVEN THOUGH A STEP DISLOCATION IS VISIBLE, THERE ALSO APPEARS TO BE TRUE AMPLIFICATION THAT REACHED THE THRESHOLD TO GIVE A POSITIVE RESULT. 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 ALL BD COR¿ CTGCTV2 COMPONENT LOTS USED BY THE CUSTOMER. THE ROOT CAUSE WAS NOT IDENTIFIED. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. BD DID NOT INITIATE A CORRECTIVE AND PREVENTIVE ACTION SINCE NO NEW HAZARD WAS IDENTIFIED. BD APOLOGIZES FOR THE INCONVENIENCE THAT THIS MAY HAVE CAUSED. BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    REPORT 1 OF 3: IT WAS REPORTED THAT DURING USE OF BD CTGCTV2 FOR BD MAX¿ SYSTEM, A FALSE POSITIVE TRICHOMONAS VAGINALIS PATIENT RESULT WAS OBTAINED. SPECIMEN GAVE UNRESOLVED RESULTS FOR OTHER ASSAY TARGETS, SO TEST WAS REPEATED WITH FULLY NEGATIVE RESULTS FOR ALL TARGETS. THERE WAS NO REPORT OF PATIENT IMPACT.

    Description of Event or Problem · 0

    REPORT 1 OF 3: IT WAS REPORTED THAT DURING USE OF BD CTGCTV2 FOR BD MAX¿ SYSTEM, A FALSE POSITIVE TRICHOMONAS VAGINALIS PATIENT RESULT WAS OBTAINED. SPECIMEN GAVE UNRESOLVED RESULTS FOR OTHER ASSAY TARGETS, SO TEST WAS REPEATED WITH FULLY NEGATIVE RESULTS FOR ALL TARGETS. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518641 BD CTGCTV2 FOR BD MAX¿ SYSTEM MULTIPLE-TYPE SEXUALLY TRANSMITTED PATHOGEN NUCLEIC ACID IVD, KIT, NUCLEIC ACID LSL GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) 4150111

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown