BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX

    MDR report key: 11490567 · Received March 16, 2021

    Report

    Report Number
    1119779-2021-00485
    Event Type
    Malfunction
    Date Received
    March 16, 2021
    Date of Event
    February 1, 2021
    Report Date
    June 10, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    QJR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.4. MEDICAL DEVICE LOT #: K20-550. D.4. MEDICAL DEVICE EXPIRATION DATE: 4/6/2021. H.4. DEVICE MANUFACTURE DATE: 11/20/2020. D.4. MEDICAL DEVICE LOT #: K20-629. D.4. MEDICAL DEVICE EXPIRATION DATE: 4/5/2021. H.4. DEVICE MANUFACTURE DATE: 12/18/2020. H.6. INVESTIGATION: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULT WHEN USING BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM (REF 444213) LOTS K20-550 AND K20-629 WAS PERFORMED BY THE REVIEW OF THE MANUFACTURING RECORDS, REVIEW OF CUSTOMER¿S DATA AND VERIFICATION OF COMPLAINTS HISTORY. THE INVESTIGATION WAS CONDUCTED BY BD AND BIOGX AND DATA ANALYSIS HAS REVEALED THAT THE KIT BIOGX SARS-COV-2 OSR WAS TESTED ALONG WITH THE EXTRACTION KIT BD MAX EXK TNA-3 LOT 0255097. REVIEW OF THE MANUFACTURING RECORDS OF BD MAX EXK TNA-3 LOT 0255097 INDICATED THAT THE LOT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. BIOGX REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT BIOGX SARS-COV-2 OSR LOTS K20-550 AND K20-629 SHOWS ACCEPTABLE PERFORMANCE CHARACTERISTICS. CUSTOMER REPORTED DISCREPANT RESULTS ON PATIENT SAMPLES WHEN USING BD BIOGX SARS COV-2 REAGENT. POSITIVE RESULTS WERE OBTAINED WITH THE BD BIOGX SARS COV-2 REAGENTS BUT WHEN REPEATED WITH ANOTHER ASSAY (CEPHEID GENEXPERT), THEY GAVE NEGATIVE RESULTS. CUSTOMER PROVIDED FIVE RUNS (#145, 180, 189, 191 AND 198) FROM THE DATABASE INSTRUMENT CT2017 FOR INVESTIGATION. THE CUSTOMER¿S UDP SETTINGS WERE VERIFIED, AND THE RESULT LOGIC PARAMETERS WERE SET IN ACCORDANCE WITH THE BIOGX SARS COV-2 PACKAGE INSERT INSTRUCTION FOR USE. CUSTOMER PROVIDED A LIST OF THE SUSPECTED POSITIVE SAMPLES. MANUAL PCR CURVE ADJUDICATION WAS CONDUCTED ON ALL SUSPECTED SAMPLES (SAMPLES INVESTIGATED: WITH KIT LOT NUMBER K20-628: #145/A11, WITH KIT LOT NUMBER K20-550: #198/B1, #189/B6, #191/B3 AND #180/A2 AS WELL AS FALSE POSITIVE SUSPECTED RESULT OBTAINED ON A QC CONTROL SAMPLE (RUN 180 LANE A2).). MANUAL CURVE ADJUDICATION HAS LIMITATIONS; VISUAL EXAMINATION OF PCR CURVES FOR LOW SIGNAL AND/OR ABERRANT CURVE GEOMETRY IS AN EXTREMELY CONSERVATIVE ASSESSMENT OF THE DATA. AMPLIFICATION CURVES OF ALL SAMPLES SHOWED TRUE BUT LOW AMPLIFICATION, WITHOUT ANOMALY. 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. SINCE THE CUSTOMER EXPERIENCED FALSE RESULTS WITH A NEGATIVE QC CONTROL, THIS SUGGESTS THAT CONTAMINATION MAY, AT LEAST IN PART, EXPLAIN SOME OF THE CUSTOMER¿S DISCREPANT RESULTS. MOREOVER, TARGETS AND LIMIT OF DETECTION VARIES BETWEEN ASSAYS. FINALLY, THE LATEST ENVIRONMENTAL MONITORING PERFORMED AT THE CUSTOMER SITE CAME BACK NEGATIVE, AFTER THE SUSPECTED CONTAMINATION, SUGGESTING THAT THE SUSPECTED CONTAMINATION ISSUE IS RESOLVED. ALTHOUGH BD WAS UNABLE TO CONFIRM THE EXACT CAUSE OF THE CUSTOMER¿S DISCREPANT RESULTS, NO PRODUCT ISSUE IS SUSPECTED. THERE IS NO INDICATION OF AN INCREASE IN COMPLAINTS FOR DISCREPANT RESULT FOR BIOGX SARS-COV-2 OSR LOTS K20-550 AND K20-629. THE ROOT CAUSE WAS NOT IDENTIFIED. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX¿ SYSTEM A HIGH LEVEL OF FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. EUA #: (B)(4).

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX¿ SYSTEM A HIGH LEVEL OF FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. EUA #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390358 BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SARS-COV-2 REAGENT KIT QJR BECTON, DICKINSON & CO. (SPARKS) SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1