BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CTGCTV2 FOR BD MAX¿ SYSTEM (US)

    MDR report key: 15577673 · Received October 11, 2022

    Report

    Report Number
    3007420875-2022-00066
    Event Type
    Malfunction
    Date Received
    October 11, 2022
    Date of Event
    September 22, 2022
    Report Date
    November 29, 2022
    Manufacturer
    GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)
    Product Code
    OUY
    UDI-DI
    00382904439040
    PMA / PMN Number
    K182692
    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

    H.6 INVESTIGATION SUMMARY: TWO OTHER COMPLAINTS WERE RECEIVED ON THE BD MAX¿ CTGCTV2 KIT LOT 2011762. THE OTHER ONE WAS FOR AN UNRELATED ISSUE. IN THE LAST TWELVE MONTHS, ONE OTHER COMPLAINT WAS RECEIVED ABOUT FALSE POSITIVE RESULT (DESCRIBED ABOVE) AND NONE ABOUT DISCREPANT RESULTS WITH THE BD MAX¿ CTGCTV2 ASSAY. BASED ON THE COMPLAINT REVIEW, NO REAGENTS ISSUE WAS IDENTIFIED. NO ANOMALY WAS OBSERVED, IN BHR REVIEW OF BD MAX¿ CTGCTV2 KIT LOT 2011762 WHICH COULD HAVE A LINK WITH THE CUSTOMER ISSUE. ALSO, THE KIT MET THE RELEASE SPECIFICATIONS AND QC RESULTS WERE WITHIN THE TRENDS. THE RETAIN MATERIAL DID NOT NEED TO BE TESTED SINCE IT WOULD NOT PROVIDE MORE INFORMATION THAN WHAT IS AVAILABLE FROM THE FINAL QC TEST. A GROSS PRODUCT CONTAMINATION WOULD HAVE BEEN DETECTED BY THE FINAL QC TEST, WHICH IS NOT THE CASE. NO SAMPLE WAS RECEIVED FOR THE INVESTIGATION. TWO RUNS WERE RECEIVED FOR THE INVESTIGATION AND WERE ANALYZED WITH THE BANCS ALGORITHM SIMULATION SOFTWARE. MANUAL PCR CURVE ADJUDICATION WAS PERFORMED AND SHOWED TRUE BUT LATE AMPLIFICATION OF THE GC TARGET IN RUN 120 POSITION A12, WITHOUT ANOMALY. OVERALL, 12 SAMPLES WERE TESTED WITH THE BD MAX¿ CTGCTV2 ASSAY IN RUN 120 ON (B)(6) AND NO OTHER SAMPLE GAVE A POSITIVE RESULT. LOW POSITIVE SAMPLES CAN OCCUR DUE TO LOW BACTERIAL LOAD 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. NEVERTHELESS, MANUAL CURVE ADJUDICATION HAS LIMITATIONS; VISUAL EXAMINATION OF PCR CURVES FOR LOW SIGNAL IS A CONSERVATIVE ASSESSMENT OF THE DATA. ON (B)(6), CUSTOMER PERFORMED ENVIRONMENTAL MONITORING (USING ONE SWAB OF MULTIPLE ZONES; RUN 134) AND IT GAVE A NEGATIVE RESULT. MOREOVER, DESPITE A NEGATIVE ENVIRONMENTAL MONITORING, ENVIRONMENTAL OR CROSS CONTAMINATION OF THE SAMPLE, COULD ALSO EXPLAIN THE ISSUE. OVERALL, ALTHOUGH BD IS UNABLE TO CONFIRM THE EXACT CAUSE OF THE ISSUE, NO REAGENTS ISSUE IS SUSPECTED.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD CTGCTV2 FOR BD MAX¿ SYSTEM (US) THERE WAS DISCREPANT RESULTS WITH ONE PATIENT SAMPLE. THE CUSTOMER REPORTED POSITIVE RESULTS FOR GC ON THAT PATIENT SAMPLE AND THE PATIENT THEN WENT TO ANOTHER HOSPITAL TO GET TESTED USING HOLOGIC PLATFORM (NOT BD) AND THE REPEAT WAS NEGATIVE. MEDICATIONS OR FOLLOW UP ARE UNKNOWN. NO PATIENT IMPACT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS MAX CTGCTV2 ASSAY DISCREPANT RESULTS ON ONE PATIENT SAMPLE. HAZARD, INJURY OR ERRONEOUS RESULTS DETAILS - DISCREPANT RESULTS WITH ANOTHER PLATFORM (NOT BD). CUSTOMER REPORTED POSITIVE RESULTS FOR GC ON 9/23/2022; VAGINAL SAMPLE; FEMALE PATIENT. PATIENT WENT TO ANOTHER HOSPITAL TO GET A NEW SAMPLE COLLECTED. THE REPEAT TEST WAS PROCESSED ON HOLOGIC PLATFORM AS NEGATIVE. PATIENT IMPACT: MEDICATIONS OR FOLLOW UP UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD CTGCTV2 FOR BD MAX¿ SYSTEM (US) THERE WAS DISCREPANT RESULTS WITH ONE PATIENT SAMPLE. THE CUSTOMER REPORTED POSITIVE RESULTS FOR GC ON THAT PATIENT SAMPLE AND THE PATIENT THEN WENT TO ANOTHER HOSPITAL TO GET TESTED USING HOLOGIC PLATFORM (NOT BD) AND THE REPEAT WAS NEGATIVE. MEDICATIONS OR FOLLOW UP ARE UNKNOWN. NO PATIENT IMPACT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS MAX CTGCTV2 ASSAY DISCREPANT RESULTS ON ONE PATIENT SAMPLE. HAZARD, INJURY OR ERRONEOUS RESULTS DETAILS - DISCREPANT RESULTS WITH ANOTHER PLATFORM (NOT BD). CUSTOMER REPORTED POSITIVE RESULTS FOR GC ON (B)(6) 2022; VAGINAL SAMPLE; FEMALE PATIENT. PATIENT WENT TO ANOTHER HOSPITAL TO GET A NEW SAMPLE COLLECTED. THE REPEAT TEST WAS PROCESSED ON HOLOGIC PLATFORM AS NEGATIVE. PATIENT IMPACT: MEDICATIONS OR FOLLOW UP UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2796328 BD CTGCTV2 FOR BD MAX¿ SYSTEM (US) UNKNOWN OUY GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) 443904 2011762 00382904439040

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown