BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MOLECULAR SWAB COLLECTION KIT

    MDR report key: 15540386 · Received October 4, 2022

    Report

    Report Number
    3007420875-2022-00061
    Event Type
    Malfunction
    Date Received
    October 4, 2022
    Date of Event
    September 28, 2022
    Report Date
    December 21, 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

    PRODUCT 443904 (BD CTGCTV2 FOR BD MAX¿ SYSTEM (US)) IS ASSOCIATED WITH PRODUCT 443925 BD MOLECULAR SWAB COLLECTION KIT, 510(K) NUMBER K182692. INFORMATION FROM THIS ASSOCIATED PRODUCT WAS USED FOR THE FOLLOWING FIELDS: DESCRIBE EVENT OR PROBLEM. MEDICAL DEVICE BRAND NAME. COMMON DEVICE NAME. MEDICAL DEVICE TYPE. PMA/510(K)#. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: REVIEW OF THE MANUFACTURING RECORDS OF THE BD MAX CTGCTV2 INDICATED THAT LOT 2011762 WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. MORE DETAILS ABOUT THE COMPLAINT WERE REQUESTED BUT NO INFORMATION WAS PROVIDED. THE INVESTIGATION WAS THUS LIMITED. THE DATABASE INCLUDED 136 RUNS TESTED WITH VARIOUS ASSAYS (GBS, VAGINAL PANEL AND CTGCTV2), OVER 3 MONTHS (B)(6) 2022. OVERALL, 813 SAMPLES WERE TESTED WITH THE BD MAX¿ CTGCTV2 ASSAY, ALL USING KIT LOT 2011762. DATABASE ANALYSIS REVEALED THAT WHEN EXCLUDING THE POSITIVE CONTROL SAMPLES, THE POSITIVITY RATE FOR THE CT TARGET DECREASED IN TIME, FROM (B)(4) IN JULY TO (B)(4) IN AUGUST AND (B)(4) IN SEPTEMBER. WITHOUT MORE DETAILS ON THE ISSUE REGARDING THE PERIOD OR NUMBER OF SAMPLES INVOLVED, ALL THE PATIENT SAMPLES THAT GAVE A CT POSITIVE RESULT IN THE MONTH OF SEPTEMBER (RUNS 63 TO 135) WERE ANALYZED AND MANUAL PCR CURVES ADJUDICATION WERE PERFORMED. AMONG 24 SAMPLES THAT GAVE A CT POSITIVE RESULT, 22 SHOWED A TRUE AMPLIFICATION CURVE, WITH MOSTLY EARLY RESULTS, ASIDE FROM 2 OF THEM WHICH GAVE A LOW AND LATE BUT TRUE AMPLIFICATION OF THE CT TARGET (RUN 98 B7 AND RUN 90 A7). 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. OTHER TARGETS WERE ALSO VERIFIED AND SHOWED NO ISSUE. FOR THE 2 REMAINING SAMPLES (RUN 118 A10 AND RUN 115 A4), A STEP DISLOCATION IN THE RAW PCR SIGNAL IN ALL CHANNELS WAS OBSERVED, RESULTING IN A POSITIVE RESULT FOR THE CT TARGET. IT IS UNLIKELY THESE POSITIVE RESULTS ARE TRUE AMPLIFICATIONS . UNFORTUNATELY, NO ROOT CAUSE COULD BE IDENTIFIED. NEVERTHELESS, MANUAL CURVE ADJUDICATION HAS LIMITATIONS; VISUAL EXAMINATION OF PCR CURVES FOR LOW SIGNAL OR ATYPICAL CURVE GEOMETRY IS A CONSERVATIVE ASSESSMENT OF THE DATA. ON SEPTEMBER 27TH, CUSTOMER PERFORMED ENVIRONMENTAL MONITORING USING A SINGLE SAMPLE (SWAB OF MULTIPLE ZONES) AND IT GAVE A NEGATIVE RESULT. OVERALL, NO REAGENT ISSUE IS SUSPECTED. THERE IS NO INDICATION OF A REAGENT ISSUE BASED ON THE ANALYSIS OF THE COMPLAINTS RECEIVED FOR DISCREPANT RESULTS ON BD MAX CTGCTV2 LOT 2011762. THE ROOT CAUSE WAS NOT IDENTIFIED. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. BD APOLOGIZES FOR THE INCONVENIENCE THAT THIS MAY HAVE CAUSED. BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD MOLECULAR SWAB COLLECTION KIT THERE WAS A HIGH POSITIVITY RATE ON THE CTGCTV2 ASSAY FOR THE CT TARGET. NO PATIENT IMPACT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS CTGCTV2 ASSAY "HIGH POSITIVITY RATE FOR CT TARGET", ACCORDING TO THEIR PROVIDERS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD MOLECULAR SWAB COLLECTION KIT THERE WAS A HIGH POSITIVITY RATE ON THE CTGCTV2 ASSAY FOR THE CT TARGET. NO PATIENT IMPACT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS CTGCTV2 ASSAY "HIGH POSITIVITY RATE FOR CT TARGET", ACCORDING TO THEIR PROVIDERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2506884 BD MOLECULAR SWAB COLLECTION KIT UNKNOWN OUY GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) 443904 2011762 00382904439040

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown