BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 16908377 · Received May 10, 2023

    Report

    Report Number
    1119779-2023-00542
    Event Type
    Malfunction
    Date Received
    May 10, 2023
    Date of Event
    April 8, 2023
    Report Date
    June 7, 2023
    Manufacturer
    GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)
    Product Code
    LSL
    UDI-DI
    00382904439040
    PMA / PMN Number
    K182692
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED: D3. MANUFACTURER NAME, CITY, AND STATE: GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) D4. MEDICAL DEVICE LOT #: 2011762 D4. MEDICAL DEVICE EXPIRATION DATE: 29-JUL-2023 G1. MANUFACTURING LOCATION: GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) H4. DEVICE MANUFACTURE DATE: 11-JAN-2023 H6. INVESTIGATION SUMMARY: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WITH THE BD (B)(4) FOR BD MAX¿ SYSTEM ASSAY (REF. 443904) LOT 2011762 WAS PERFORMED BY THE REVIEW OF MANUFACTURING RECORDS, CUSTOMER¿S DATA ANALYSIS AND VERIFICATION OF COMPLAINTS HISTORY. REVIEW OF THE MANUFACTURING RECORDS OF BD (B)(4) FOR BD MAX¿ SYSTEM ASSAY INDICATED THAT LOT 2011762 WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER REPORTED SUSPECTED FALSE POSITIVE RESULTS WITH THE BD (B)(4) FOR BD MAX¿ SYSTEM ASSAY. NO KIT LOT WAS ORIGINALLY PROVIDED FOR THE COMPLAINT, ANALYSIS OF THE CUSTOMER DATA REVEALED THAT THE KIT LOT USED WAS 2011762 AND WAS INCLUDED IN THE INVESTIGATION. CUSTOMER PROVIDED DATABASE OF INSTRUMENT (B)(4) FOR THE INVESTIGATION. DATABASE ANALYSIS SHOWED THAT ALL THE RUNS TESTED WITH THE BD (B)(4) FOR BD MAX¿ SYSTEM ASSAY SEEM TO CONTAIN VALIDATION SAMPLES (9 RUNS: 2925, 2932, 2937, 3366, 3367, 3370, 3373, 3380 AND 3413). THREE RUNS (2925, 2932 AND 2937) EACH CONTAIN 4 SAMPLES AND THE RESULTS REPEAT IN THE SAME POSITION OVER THE THREE RUNS, SUGGESTING THAT THE SAME CONTROLS OR VALIDATION SAMPLES WERE REPEATED IN THESE THREE RUNS. FOR THE REMAINING RUNS, THE CUSTOMER TESTED SEVERAL SAMPLES WITH BOTH BD MAX¿ (B)(4) AND BD (B)(4) FOR BD MAX¿ SYSTEM, AND NO DISCREPANT RESULT WAS OBTAINED BETWEEN BOTH KITS. MANUAL PCR CURVE ADJUDICATION REVEALED STRONG POSITIVE AMPLIFICATION WITHOUT ANOMALY. THE POSITIVE AND NEGATIVE CONTROLS TESTED AMONG THE RUNS CONSISTENTLY GAVE THE EXPECTED RESULTS ASIDE FROM ONE UNRESOLVED RESULT OBTAINED FOR A SAMPLE IDENTIFIED ¿QC POS¿ IN RUN 3380. OVERALL, BASED ON THE DATA PROVIDED, NO ISSUE WAS OBSERVED. ALL THE RESULTS WERE VALID AND WERE REPEATED WITHOUT ANOMALY. THE ANALYSIS DOES NOT SUGGEST ANY FALSE POSITIVE RESULT. THERE IS NO INDICATION OF A REAGENT ISSUE BASED ON THE ANALYSIS OF THE COMPLAINTS RECEIVED FOR DISCREPANT RESULTS ON BD (B)(4) FOR BD MAX¿ SYSTEM ASSAY LOT 2011762. 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 (CAPA) SINCE NO NEW HAZARD WAS IDENTIFIED. BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS.

    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 AN UNSPECIFIED BD MAX KIT A HIGH POSITIVITY RATE OF DISCREPANT RESULTS HAVE OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HIGH POSITIVITY RATE WITH A HIGH INCIDENCE OF DISCREPANT RESULTS BETWEEN OUR MAX INSTRUMENT, CULTURE, REVOGENE AND ANOTHER MAX INSTRUMENT AT A DIFFERENT HOSPITAL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING AN UNSPECIFIED BD MAX KIT A HIGH POSITIVITY RATE OF DISCREPANT RESULTS HAVE OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HIGH POSITIVITY RATE WITH A HIGH INCIDENCE OF DISCREPANT RESULTS BETWEEN OUR MAX INSTRUMENT, CULTURE, REVOGENE AND ANOTHER MAX INSTRUMENT AT A DIFFERENT HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688216 UNKNOWN UNKNOWN LSL GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) 443904 2011762 00382904439040

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown