BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM

    MDR report key: 17801388 · Received September 22, 2023

    Report

    Report Number
    1119779-2023-01025
    Event Type
    Malfunction
    Date Received
    September 22, 2023
    Date of Event
    September 1, 2023
    Report Date
    August 14, 2025
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    QJR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT WHILE USING BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM THAT THERE WAS A FALSE POSITIVE. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION HAS BEEN UPDATED: MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 2291561 D.4. MEDICAL DEVICE EXPIRATION DATE: 2023-12-12 H.4. DEVICE MANUFACTURE DATE: 2022-10-18 D.4. MEDICAL DEVICE LOT #: 2242401 D.4. MEDICAL DEVICE EXPIRATION DATE: 2023-10-24 H.4. DEVICE MANUFACTURE DATE: 2022-08-30 H.6. INVESTIGATION SUMMARY: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WHEN USING THE BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM KIT (REF. 44500301) LOTS 2242401 AND 2291561 WAS PERFORMED BY THE REVIEW OF MANUFACTURING RECORDS, REVIEW OF CUSTOMER¿S DATA, AND VERIFICATION OF COMPLAINTS HISTORY. REVIEW OF THE MANUFACTURING RECORDS OF THE BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM KIT INDICATED THAT LOTS 2242401 AND 2291561 WERE MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER COMPLAINED ABOUT FALSE POSITIVE RESULTS OBTAINED WITH THE BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM KITS. CUSTOMER PROVIDED PDF RUNS FILES OF ONE PATIENT SAMPLE (#3999/A12) AND MULTIPLE ENVIRONMENTAL MONITORING SAMPLES (#3999, 4008, 4017, 4018, 4039 AND 4045) FROM INSTRUMENT CT1175 AND TWO OTHER RUN FILES (#1363 AND 1364) FROM INSTRUMENT CT2083. THE PCR CURVES OF THESE SAMPLES SHOWED LATE AMPLIFICATIONS (CT VALUES >35) OF N1 OR N2 TARGETS WITHOUT ANOMALY INDICATIVE OF TRUE LOW POSITIVE RESULTS. MOREOVER, DURING A VISIT AT CUSTOMER SITE OF A BD MOLECULAR APPLICATION SPECIALIST FOR ASSISTANCE TO LABORATORY CLEANING AND PERFORM ENVIRONMENTAL RUNS, AN ENVIRONMENTAL CONTAMINATION WAS FOUND. THIS CONTAMINATION COULD COME FROM ANOTHER PCR-BASED INSTRUMENT (BIOFIRE) WHICH IS CLOSE TO THE BD MAX INSTRUMENTS. THIS WAS SUSPECTED BECAUSE DURING ENVIRONMENTAL MONITORING AT THE SITE, THE CUSTOMER USED A NEW SAMPLE BUFFER TUBE WHICH WAS OPENED AND LEFT ON THE COUNTER OVERNIGHT, BETWEEN THE BD MAX AND BIOFIRE INSTRUMENTS. UPON TESTING ON THE BD MAX INSTRUMENT, THE FOLLOWING DAY, A LATE N1 POSITIVE RESULT WAS OBTAINED (SAMPLE TESTED IN RUN 1364, INSTRUMENT CT2083). BASED ON THE DATA AND INFORMATION PROVIDED, ENVIRONMENTAL TARGET CONTAMINATION AT CUSTOMER SITE IS THE MOST LIKELY CAUSE TO EXPLAIN THE CUSTOMER¿S POSITIVE RESULTS, BUT THE INVESTIGATION DOES NOT SUGGEST ANY REAGENTS ISSUE. THERE IS NO INDICATION OF A REAGENT ISSUE BASED ON THE ANALYSIS OF THE COMPLAINTS RECEIVED FOR DISCREPANT RESULTS ON BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM KIT LOTS 2242401 AND 2291561. 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 APOLOGIZES FOR THE INCONVENIENCE THAT THIS MAY HAVE CAUSED. BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS. H3 OTHER TEXT : SEE H.10

    Additional Manufacturer Narrative · 0

    G.5 PMA / 510(K)#: EUA(B)(4). H.3. 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

    THE FOLLOWING UPDATES HAVE BEEN MADE: THIS MDR PERTAINS ONLY TO LOT NUMBER 2291561. B5. IT WAS REPORTED WHILE USING BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM, THERE WERE AN UNKNOWN NUMBER OF FALSE POSITIVE RESULTS. THERE WAS NO REPORT OF PATIENT IMPACT. THIS RECORD IS BEING REOPENED TO ADDRESS THE CORRECTIONS REQUIRED FOR CAPA PR 11910483.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM THAT THERE WAS A FALSE POSITIVE. NO PATIENT IMPACT REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM THAT THERE WAS A FALSE POSITIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THEY ARE FINDING SOME FALSE POSITIVE RESULTS WHEN RUNNING COVID. MAX 44500301 LOT 2291561 FALSE POSITIVE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM, THERE WERE AN UNKNOWN NUMBER OF FALSE POSITIVE RESULTS. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1873331 BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM SARS-COV-2 REAGENT KIT QJR BECTON DICKINSON & CO. (SPARKS) SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown