BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAX¿ CPO

    MDR report key: 20356164 · Received October 2, 2024

    Report

    Report Number
    3007420875-2024-00094
    Event Type
    Malfunction
    Date Received
    October 2, 2024
    Date of Event
    August 29, 2024
    Report Date
    December 20, 2024
    Manufacturer
    GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)
    Product Code
    OOI
    UDI-DI
    00382904452629
    PMA / PMN Number
    K190613
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WHEN USING BD MAX¿ CPO (REF. (B)(4) ) KIT LOT 4023878 WAS PERFORMED BY THE REVIEW OF MANUFACTURING RECORDS, REVIEW OF CUSTOMER¿S DATA AND BY THE COMPLAINT¿S HISTORY REVIEW. CUSTOMER REPORTED OBTAINING DISCREPANT RESULTS FOR THE OXA TARGET WHEN REPEATING A SAME SAMPLE WHEN USING BD MAX¿ CPO (REF. 443979) KIT LOT 4023878. THE SAMPLE TESTED POSITIVE TWO TIMES AND NEGATIVE ONE TIME ALTHOUGH THE CUSTOMER COULD OBSERVE A VISIBLE CURVE. THE SAMPLE ALSO TESTED NEGATIVE WHEN ANOTHER TESTING METHOD WAS USED. REVIEW OF THE MANUFACTURING RECORDS OF BD MAX¿ CPO INDICATED THAT LOT 4023878 WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER PROVIDED RUNS 1705, 1710 AND 1716 FROM BD MAX INSTRUMENT CT0562 FOR INVESTIGATION. MANUAL PCR CURVE ADJUDICATION WAS CONDUCTED ACROSS THE DISCREPANT SAMPLES. THE TWO POSITIVE RESULTS (RUN 1705; POSITION A6 AND 1716; B5) SHOW REAL AMPLIFICATION CURVES, NO ISSUE IS SUSPECTED, AND THERE IS NO INDICATION OF A FALSE RESULT. THE SAMPLE IN RUN 1710; POSITION B4, WHICH OBTAINED A NEGATIVE RESULT, SHOWS A LATE AND LOW AMPLIFICATION CURVE, SUGGESTING A BACTERIAL LOAD BELOW ASSAY LIMIT OF DETECTION FOR THE OXA TARGET. MOREOVER, ANALYSIS REVEALED THAT THE REPEAT TESTS WERE NOT DONE USING THE SAME SAMPLE TUBE. KNOWING THAT A NEW SAMPLE WAS PREPARED, THE REPEAT TEST MAY HAVE CONTAINED A LOWER CONCENTRATION OF TARGET, EXPLAINING THE NEGATIVE RESULT. MANUAL CURVE ADJUDICATION HAS LIMITATIONS; VISUAL EXAMINATION OF PCR CURVES FOR LOW SIGNAL IS A CONSERVATIVE ASSESSMENT OF THE DATA. NO INFORMATION WAS PROVIDED CONCERNING THE OTHER METHOD OF TESTING USED. SINCE LIMIT OF DETECTION CAN VARY BETWEEN DIFFERENT ASSAYS, THIS COULD EXPLAIN THE DISCREPANCIES BETWEEN TESTS. THERE IS NO INDICATION OF A REAGENT ISSUE BASED ON THE ANALYSIS OF THE COMPLAINTS RECEIVED FOR DISCREPANT RESULTS ON BD MAX¿ CPO (REF. 443979) KITS. THE ROOT CAUSE WAS NOT IDENTIFIED. HOWEVER, SAMPLES AT OR NEAR THE LIMIT OF DETECTION OF THE ASSAY (LOD) COULD EXPLAIN CUSTOMER¿S ISSUE. 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 OR TRENDS WAS IDENTIFIED BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    D.2. ADDITIONAL MEDICAL DEVICE TYPE: PCH. D.4. COMMON DEVICE NAME: SYSTEM, NUCLEIC ACID AMPLIFICATION TEST, DNA, ANTIMICROBIAL RESISTANCE MARKER, DIRECT SPECIMEN. D.4. MEDICAL DEVICE LOT: UNKNOWN, D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN, H.4. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF BD MAX¿ CPO ASSAY, A DISCREPANT PATIENT RESULT WAS OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FIRST TEST GAVE A POSITIVE RESULT FOR OXA-48. THE SECOND TEST GAVE AN OXA-48 NEGATIVE RESULT BUT CURVE WAS VISIBLE. THE THIRD TEST GAVE ANOTHER OXA-48 POSITIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF BD MAX¿ CPO ASSAY, A DISCREPANT PATIENT RESULT WAS OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FIRST TEST GAVE A POSITIVE RESULT FOR OXA-48. THE SECOND TEST GAVE AN OXA-48 NEGATIVE RESULT BUT CURVE WAS VISIBLE. THE THIRD TEST GAVE ANOTHER OXA-48 POSITIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1091648 BD MAX¿ CPO MULTIPLE-GENUS RESPIRATORY VIRUS NUCLEIC ACID IVD, KIT, NUCLEIC ACID TECHNIQUE OOI GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) 00382904452629

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown