BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAX¿ CHECK-POINTS (CPO)

    MDR report key: 23066926 · Received September 16, 2025

    Report

    Report Number
    3007420875-2025-00159
    Event Type
    Malfunction
    Date Received
    September 16, 2025
    Date of Event
    August 11, 2025
    Report Date
    December 4, 2025
    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
    CI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THE COMPLAINT INVESTIGATION FOR SUSPECTED FALSE NEGATIVE RESULTS WHEN USING BD MAX¿ CPO (REF. 445262) KIT LOT 5021084 WAS PERFORMED BY THE REVIEW OF MANUFACTURING RECORDS, RETAIN MATERIAL TESTING, REVIEW OF CUSTOMER¿S DATA AND BY THE COMPLAINT¿S HISTORY REVIEW. THE REVIEW OF QUALITY CONTROL RECORDS OF BD MAX¿ CPO LOT 5021084 REVEALED NO ANOMALIES THAT COULD EXPLAIN THE CUSTOMER¿S NEGATIVE RESULTS. THE RETAIN MATERIAL OF BD MAX¿ CPO FROM LOT 5021084 WAS VISUALLY INSPECTED AND TESTED. THE RESULTS WERE AS EXPECTED. CUSTOMER COMPLAINED ABOUT AN AMPLIFICATION CURVE IN THE ROX CHANNEL (OXA TARGET) THAT GAVE OXA NEGATIVE RESULT WITH THE BD MAX¿ CPO KIT LOT 5021084, WHILE CULTURE WAS POSITIVE, AND IMMUNOCHROMATOGRAPHY YIELDED OXA. CUSTOMER PROVIDED RUN FILES OF RUN 444 FROM BD MAX¿ INSTRUMENT CT3187 FOR INVESTIGATION. MANUAL PCR CURVE ADJUDICATION OF THE OXA NEGATIVE SAMPLE IN POSITION A4 REVEALED A LATE AND LOW AMPLIFICATION WHICH DID NOT REACH THE THRESHOLD TO BE CONSIDERED POSITIVE. INTERNAL CONTROL AMPLIFICATION REVEALED NO ANOMALY. NEVERTHELESS, MANUAL CURVE ADJUDICATION HAS LIMITATIONS; VISUAL EXAMINATION OF PCR CURVES FOR LOW SIGNAL IS A CONSERVATIVE ASSESSMENT OF THE DATA. NEVERTHELESS, THIS ISSUE DID NOT AFFECT INTERNAL CONTROL AMPLIFICATION. IT MUST BE NOTED THAT MANUAL CURVE ADJUDICATION HAS LIMITATIONS; VISUAL EXAMINATION OF PCR CURVES FOR LOW SIGNAL IS A CONSERVATIVE ASSESSMENT OF THE DATA. BASED ON THE DATA AND INFORMATION PROVIDED, SPECIMEN AT OR NEAR THE ASSAY LIMIT OF DETECTION (LOD) IS THE MOST LIKELY CAUSE TO EXPLAIN THE CUSTOMER¿S NEGATIVE RESULT. THERE IS NO INDICATION OF A REAGENT ISSUE BASED ON THE ANALYSIS OF THE COMPLAINTS RECEIVED FOR DISCREPANT RESULTS ON BD MAX¿ CPO KIT LOT 5021084. THE ROOT CAUSE WAS NOT IDENTIFIED. HOWEVER, A SAMPLE WITH A CONCENTRATION BEYOND THE CT VALUES LIMITS OF DETECTION OF THE ASSAY IS THE MOST LIKELY CAUSE TO EXPLAIN THE CUSTOMER¿S DISCREPANT RESULTS. 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 WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    D.2. ADDITIONAL MEDICAL DEVICE TYPES: POC. 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, A FALSE NEGATIVE OXA PATIENT RESULT WAS OBTAINED. CULTURE WAS PERFORMED AND RESULT WAS VIM/IMP POSITIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF BD MAX¿ CPO, A FALSE NEGATIVE OXA PATIENT RESULT WAS OBTAINED. CULTURE WAS PERFORMED AND RESULT WAS VIM/IMP POSITIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552148 BD MAX¿ CHECK-POINTS (CPO) MULTIPLE-GENUS RESPIRATORY VIRUS NUCLEIC ACID IVD KIT OOI GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) 5021084 00382904452629

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown