BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAX¿ GBS

    MDR report key: 20241668 · Received September 17, 2024

    Report

    Report Number
    3007420875-2024-00078
    Event Type
    Malfunction
    Date Received
    September 17, 2024
    Date of Event
    August 19, 2024
    Report Date
    October 29, 2024
    Manufacturer
    GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)
    Product Code
    OOI
    UDI-DI
    00382904417727
    PMA / PMN Number
    K111860
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D.2. ADDITIONAL MEDICAL DEVICE TYPE: NJR. 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 GBS KIT (REF. 441772) LOT: 4082311 WAS PERFORMED BY THE REVIEW OF MANUFACTURING RECORDS, REVIEW OF CUSTOMER¿S DATA AND BY THE COMPLAINT¿S HISTORY REVIEW. CUSTOMER COMPLAINED ABOUT OBTAINING A POSITIVE RESULT THAT REPEATED AS NEGATIVE WHEN USING BD MAX¿ GBS KIT LOT: 4082311. REPEAT WAS PERFORMED FROM A NEW SBT USING THE SAME LIM BROTH PREPARATION. REVIEW OF MANUFACTURING RECORDS OF THE BD MAX GBS INDICATED THAT THE LOT: 4082311 WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER PROVIDED RUNS 2853, 2854, 3890 AND 3891 FROM INSTRUMENT CT1273 FOR INVESTIGATION. CUSTOMER IDENTIFIED POSITIVE SAMPLE IN RUN 3890; POSITION A3 THAT REPEATED NEGATIVE IN RUN 3891; POSITION B7 AS TO BE INVESTIGATED. MANUAL PCR CURVE ADJUDICATION WAS CONDUCTED ACROSS THE DISCREPANT SAMPLES. ORIGINAL TESTS SHOWED LATE AMPLIFICATION OF THE GBS TARGET IN THE FAM CHANNEL, WHICH IS UNEXPECTED WITH THE BD MAX¿ GBS ASSAY, SINCE SAMPLES ARE TESTED FOLLOWING AN ENRICHMENT STEP. NO AMPLIFICATION IN THE FAM CHANNEL (GBS TARGET) WAS OBSERVED FOR ALL THE REPEAT TESTS, AND A NEGATIVE RESULT IS THE EXPECTED RESULT IN SUCH CASES. 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 MAX GBS LOT: 4082311. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. HOWEVER, CROSS-CONTAMINATION DURING SAMPLE PREPARATION COULD EXPLAIN THE CUSTOMER¿S ISSUE. BD DID NOT INITIATE A CORRECTIVE AND A PREVENTIVE ACTION PLAN SINCE NO NEW HAZARD OR TRENDS WAS IDENTIFIED. BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF BD MAX¿ GBS, A FALSE POSITIVE PATIENT RESULT WAS OBTAINED. SAMPLE WAS REPEATED AND THE RESULT WAS GBS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF BD MAX¿ GBS, A FALSE POSITIVE PATIENT RESULT WAS OBTAINED. SAMPLE WAS REPEATED AND THE RESULT WAS GBS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1808940 BD MAX¿ GBS NUCLEIC ACID AMPLIFICATION ASSAY SYSTEM, GROUP B STREPTOCOCCUS, DIRECT SPECIMEN OOI GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) 4082311 00382904417727

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown