BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAX¿ CPO

    MDR report key: 22012836 · Received May 13, 2025

    Report

    Report Number
    3007420875-2025-00074
    Event Type
    Malfunction
    Date Received
    May 13, 2025
    Date of Event
    December 27, 2024
    Report Date
    May 28, 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
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED BECAUSE INVESTIGATION FOUND THAT THE INITIAL MDR WAS FILED AGAINST INCORRECT PRODUCT: B5: DESCRIPTION OF EVENT: REPORT 1 OF 2: IT WAS REPORTED THAT DURING USE OF BD MAX¿ CHECK-POINTS (CPO), AN UNSPECIFIED NUMBER OF FALSE POSITIVE PATIENT RESULTS WERE OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT. D1: MEDICAL DEVICE BRAND NAME: BD MAX¿ CPO D2A: COMMON DEVICE NAME: MULTIPLE-GENUS RESPIRATORY VIRUS NUCLEIC ACID IVD, KIT, NUCLEIC ACID TECHNIQUE D2B: MEDICAL DEVICE TYPE: OOI, POC D4: CATALOG: 445262 D4: LOT: 4082387 D4: EXP DATE: 03/21/2025 UDI#: (B)(4). G4: PMA/510(K)#: K190613 INVESTIGATION SUMMARY: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WHEN USING BD MAX¿ CPO (REF. (B)(4) KIT LOTS 4082387 WAS PERFORMED BY THE REVIEW OF MANUFACTURING RECORDS, REVIEW OF CUSTOMER¿S DATA AND BY THE COMPLAINT¿S HISTORY REVIEW. CUSTOMER COMPLAINED OF FOUR SAMPLES WITH SUSPECTED FALSE POSITIVE RESULTS FOR THE KPC TARGET WITH BD MAX¿ CPO KIT LOTS 4082387 (A1, A2 AND A3). CUSTOMER PROVIDED RUN FILES (PDF AND CSV) FOR RUN 7080 FROM BD MAX¿ INSTRUMENT MX0057 FOR INVESTIGATION. MANUAL PCR CURVE ADJUDICATION WAS CONDUCTED ACROSS SAMPLES A1, A2, A3 AND A4, REVEALING STEP DISLOCATIONS AND ATYPICAL CURVES WITHOUT SIGMOIDAL SHAPE IN EVERY CHANNEL, INCLUDING THE FAM CHANNEL (KPC TARGET), FOR ALL SAMPLES, REACHING THE THRESHOLD TO GIVE POSITIVE RESULTS FOR THE KPC TARGET. IT IS UNLIKELY THAT THE STEP DISLOCATIONS ARE DUE TO TRUE AMPLIFICATION AND A ROOT CAUSE COULD NOT BE IDENTIFIED. MANUAL CURVE ADJUDICATION HAS LIMITATIONS; VISUAL EXAMINATION OF PCR CURVES FOR ABERRANT CURVE GEOMETRY 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¿ CPO (REF. (B)(4) KIT LOTS 4082387. 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 SINCE NO NEW HAZARD WAS IDENTIFIED. BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WHEN USING BD MAX¿ CPO (REF. (B)(4)) KIT LOT 4233905 WAS PERFORMED BY THE REVIEW OF MANUFACTURING RECORDS, REVIEW OF CUSTOMER¿S DATA AND BY THE COMPLAINT¿S HISTORY REVIEW. CUSTOMER COMPLAINED OF FOUR SAMPLES WITH SUSPECTED FALSE POSITIVE RESULTS FOR THE KPC TARGET WITH BD MAX¿ CPO KIT LOT 4233905 (A4). CUSTOMER PROVIDED RUN FILES (PDF AND CSV) FOR RUN 7080 FROM BD MAX¿ INSTRUMENT MX0057 FOR INVESTIGATION. MANUAL PCR CURVE ADJUDICATION WAS CONDUCTED ACROSS SAMPLES A1, A2, A3 AND A4, REVEALING STEP DISLOCATIONS AND ATYPICAL CURVES WITHOUT SIGMOIDAL SHAPE IN EVERY CHANNEL, INCLUDING THE FAM CHANNEL (KPC TARGET), FOR ALL SAMPLES, REACHING THE THRESHOLD TO GIVE POSITIVE RESULTS FOR THE KPC TARGET. IT IS UNLIKELY THAT THE STEP DISLOCATIONS ARE DUE TO TRUE AMPLIFICATION AND A ROOT CAUSE COULD NOT BE IDENTIFIED. MANUAL CURVE ADJUDICATION HAS LIMITATIONS; VISUAL EXAMINATION OF PCR CURVES FOR ABERRANT CURVE GEOMETRY 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¿ CPO (REF. (B)(4)). 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 SINCE NO NEW HAZARD WAS IDENTIFIED. BD APOLOGIZES FOR THE INCONVENIENCE THAT THIS MAY HAVE CAUSED. BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    REPORT 2 OF 2: IT WAS REPORTED THAT DURING USE OF BD MAX¿ CHECK-POINTS (CPO), AN UNSPECIFIED NUMBER OF FALSE POSITIVE PATIENT RESULTS WERE OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT.

    Description of Event or Problem · 0

    REPORT 2 OF 2: IT WAS REPORTED THAT DURING USE OF BD MAX¿ CHECK-POINTS (CPO), AN UNSPECIFIED NUMBER OF FALSE POSITIVE PATIENT RESULTS WERE OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    879868 BD MAX¿ CPO MULTIPLE-GENUS RESPIRATORY VIRUS NUCLEIC ACID IVD, KIT, NUCLEIC ACID TECHNIQUE OOI GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) 4233905 00382904452629

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown