BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 13254343 · Received January 13, 2022

    Report

    Report Number
    1119779-2021-02154
    Event Type
    Malfunction
    Date Received
    January 13, 2022
    Date of Event
    December 21, 2021
    Report Date
    March 1, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    QJR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EUA # (B)(4). 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

    H.6. INVESTIGATION: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WHEN USING THE BD SARS-COV-2 REAGENTS KIT (REF. 44500301) LOT 1243878 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 INDICATED THAT LOT 1243878 WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER REPORTED TWO DISCREPANT RESULTS WITH BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM KIT LOT 1243878. POSITIVE RESULTS WERE OBTAINED IN THE INITIAL TEST BUT WHEN REPEATED, THE SAMPLES GAVE A NEGATIVE RESULT. CUSTOMER PROVIDED PDF REPORTS OF RUNS 1548 AND 1554 FROM INSTRUMENT CT2028. THE CUSTOMER¿S UDP SETTINGS WERE VERIFIED, AND THE RESULT LOGIC PARAMETERS WERE SET IN ACCORDANCE WITH THE BD SARS-COV-2 REAGENT¿S INSTRUCTION FOR USE. HOWEVER, THE CUSTOMER ADDED A COLOR COMPENSATION VALUE OF 1.5 APPLIED FROM THE CY5 CHANNEL TO THE ROX CHANNEL. ALTHOUGH THIS IS NOT SUSPECTED OF BEING LINKED TO THE CUSTOMER ISSUE, IT IS RECOMMENDED THAT CUSTOMER CORRECTS THE PACKAGE INSERT UDP PARAMETERS. ALSO, COMPLAINT MENTIONED THAT THE CUSTOMER IS USING THE REMEL M4RT TRANSPORT MEDIA, WHICH IS OFF-LABEL USE SINCE THIS IS NOT A RECOMMENDED MEDIA FOR THIS ASSAY. AGAIN, ALTHOUGH THIS IS NOT SUSPECTED OF BEING LINKED TO THE ISSUE, BD RECOMMENDS THAT CUSTOMER USES A TRANSPORT MEDIA LISTED IN THE PACKAGE INSERT. THE CUSTOMER SUSPECTED 2 FALSE POSITIVE RESULTS (RUN #1548, POSITIONS A8 AND B4). BOTH SAMPLES WERE RECOLLECTED AND RETESTED AND GAVE NEGATIVE RESULTS (RUN #1554, POSITIONS B5 AND B3), THEY WERE ALSO NEGATIVE WHEN RETESTED USING ANOTHER ASSAY (COBAS® LIAT® PCR SYSTEM, ROCHE). UNFORTUNATELY, THE PDF REPORTS DID NOT CONTAIN ANY GRAPHS, IT WAS THUS NOT POSSIBLE TO PERFORM FURTHER ANALYSIS. NONETHELESS, FOR SAMPLE IN B4 IN RUN #1548, BOTH N1 AND N2 TARGETS DISPLAYED A CT OF 37, WHICH IS CONSIDERED AS LATE AMPLIFICATION AND COULD SUGGEST THAT THIS SAMPLE IS AT THE LIMIT OF DETECTION OF THE ASSAY. LOW POSITIVE SAMPLES CAN OCCUR DUE TO VIRAL TITERS IN THE SPECIMEN BEING AT OR NEAR THE LIMIT OF DETECTION OF THE ASSAY OR THROUGH ENVIRONMENTAL OR CROSS CONTAMINATION INTRODUCED DURING THE SAMPLE PREPARATION AT THE CUSTOMER¿S SITE. MOREOVER, LIMIT OF DETECTION CAN VARY BETWEEN DIFFERENT ASSAYS. ACCORDING TO THE COMPLAINT TEXT, THE LAST ENVIRONMENTAL MONITORING DID NOT INDICATE ANY CONTAMINATION SITES AND NO POSITIVE RESULT WAS OBTAINED. SINCE NO OTHER DATA WAS PROVIDED, THE INVESTIGATION WAS LIMITED. WITHOUT MORE DATA, BD IS UNABLE TO IDENTIFY A CAUSE FOR THE CUSTOMER ISSUE, BUT NO REAGENTS ISSUE IS SUSPECTED. 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 KIT LOT 1243878. THE ROOT CAUSE WAS NOT IDENTIFIED. HOWEVER, POSITIVES SAMPLES AT THE LIMIT OF DETECTION OF THE ASSAY OR A THROUGH ENVIRONMENTAL OR CROSS CONTAMINATION INTRODUCED DURING THE SAMPLE PREPARATION AT THE CUSTOMER¿S SITE CAN EXPLAIN THE CUSTOMER DISCREPANT SAMPLES. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. BD DID NOT INITIATE A CORRECTIVE AND PREVENTIVE ACTION (CAPA) SINCE NO REAGENT ISSUE WAS IDENTIFIED. BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE TESTING WITH THE BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM, A DISCREPANT RESULT WAS OBTAINED. CONFIRMATORY PCR TESTING WAS PERFORMED ON THE ROCHE LIAT, AND THE RESULT WAS NEGATIVE. POSITIVE RESULTS WERE REPORTED OUT, BUT THERE WAS NO REPORT OF PATIENT IMPACT. EUA # (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TWO EMPLOYEES TESTED POSITIVE; SAMPLES WERE RE-COLLECTED, AND BOTH TESTED NEGATIVE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE TESTING WITH THE BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM, A DISCREPANT RESULT WAS OBTAINED. CONFIRMATORY PCR TESTING WAS PERFORMED ON THE ROCHE LIAT, AND THE RESULT WAS NEGATIVE. POSITIVE RESULTS WERE REPORTED OUT, BUT THERE WAS NO REPORT OF PATIENT IMPACT. EUA # (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TWO EMPLOYEES TESTED POSITIVE; SAMPLES WERE RE-COLLECTED, AND BOTH TESTED NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1403787 BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM SARS-COV-2 REAGENT KIT QJR BECTON, DICKINSON & CO. (SPARKS) 1243878

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown