BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 12283029 · Received August 5, 2021

    Report

    Report Number
    1119779-2021-01312
    Event Type
    Malfunction
    Date Received
    August 5, 2021
    Date of Event
    July 9, 2021
    Report Date
    October 25, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    QJR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULT WHEN USING BIOGX SARS-COV-2 FOR BD MAX SYSTEM (REF 444213) LOT K21-218 IN COMBINATION WITH THE BD MAX¿ EXK¿ TNA-3 (442827) LOT #0255097 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. REVIEW OF THE MANUFACTURING RECORDS OF THE BD MAX¿ EXK¿ TNA-3 INDICATED THAT THE LOT 0255097 AND 1075135 WERE MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. BIOGX REVIEW OF THE QUALITY CONTROL TESTING DATA INDICATES THAT KIT LOT K21-218 PERFORMS AS EXPECTED AND MEET BIOGX PERFORMANCE CRITERIA. CUSTOMER REPORTED ONE N1 POSITIVE SAMPLE WHICH WAS NEGATIVE UPON REPEAT WITH THE BD BIOGX SARS-COV-2 FOR BD MAX¿ SYSTEM ASSAY KIT LOT K21-218. CUSTOMER PROVIDED TWO RUN FILES (RUNS #1553 AND #1557) FROM INSTRUMENT CT1496 FOR INVESTIGATION. THE CUSTOMER¿S UDP SETTINGS WERE VERIFIED, AND THE RESULT LOGIC PARAMETERS WERE SET IN ACCORDANCE WITH THE BIOGX SARS-COV-2 FOR BD MAX SYSTEM INSTRUCTION FOR USE. MANUAL PCR CURVE ADJUDICATION WAS PERFORMED. ANALYSIS OF PCR CURVES REVEALED TRUE BUT LOW POSITIVE AMPLIFICATION FOR THE N1 TARGET IN RUN 1553 SAMPLE POSITION A6, BUT NEGATIVE UPON REPEAT IN RUN 1557. THE CUSTOMER MENTIONED THAT THE REPEAT SAMPLE WAS RECOLLECTED AND RETESTED ON THE SAME DAY. LOW POSITIVE SAMPLES CAN OCCUR DUE TO VIRAL TITERS IN THE SPECIMEN BEING AT OR NEAR THE LIMIT OF DETECTION (LOD) 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. NEVERTHELESS, 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, SPECIMENS AT OR NEAR THE ASSAY LIMIT OF DETECTION (LOD) OR ENVIRONMENTAL OR CROSS CONTAMINATION ARE THE MOST LIKELY CAUSES TO EXPLAIN THE CUSTOMER¿S POSITIVE RESULTS. NO PRODUCT ISSUE IS SUSPECTED. THERE IS NO INDICATION OF AN INCREASE IN COMPLAINTS FOR DISCREPANT RESULTS FOR THE BIOGX SARS-COV-2 FOR BD MAX SYSTEM LOT K21-218. THE ROOT CAUSE WAS NOT IDENTIFIED. NOTE THAT 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). BD APOLOGIZES FOR THE INCONVENIENCE THAT THIS MAY HAVE CAUSED. BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING FOR SARS-COV-2 WITH BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX¿ SYSTEM A FALSE POSITIVE RESULT WAS OBTAINED. A SAMPLE WAS RECOLLECTED AND THE RESULTS WERE NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT. EUA# (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS THAT THEY HAD ONE PATIENT POSITIVE FOR N1. UPON REPEAT ON THE SAME DAY AND AFTER RECOLLECTING A NEW SPECIMEN, THE RESULT WAS NEGATIVE FOR ALL TARGETS. RESULTS WAS INITIALLY REPORTED TO PATIENTS, WHO THEN REQUESTED TEST TO BE REPEATED. EM AND QC WERE PERFORMED ON (B)(6) 2021 AND RESULTS WERE ACCEPTABLE. NO BUBBLES NOTICED IN PCR CARTRIDGE. SAMPLE WAS NP IN ESWAB. CUSTOMER USED 750ULOF THE SAMPLE.

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. INITIAL REPORTER ADDITIONAL PHONE #: (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE TESTING FOR SARS-COV-2 WITH BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX¿ SYSTEM A FALSE POSITIVE RESULT WAS OBTAINED. A SAMPLE WAS RECOLLECTED AND THE RESULTS WERE NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT. EUA# (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS THAT THEY HAD ONE PATIENT POSITIVE FOR N1. UPON REPEAT ON THE SAME DAY AND AFTER RECOLLECTING A NEW SPECIMEN, THE RESULT WAS NEGATIVE FOR ALL TARGETS. RESULTS WAS INITIALLY REPORTED TO PATIENTS, WHO THEN REQUESTED TEST TO BE REPEATED. EM AND QC WERE PERFORMED ON (B)(6) 2021 AND RESULTS WERE ACCEPTABLE. NO BUBBLES NOTICED IN PCR CARTRIDGE. SAMPLE WAS NP IN ESWAB. CUSTOMER USED 750ULOF THE SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1181388 BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX¿ SYSTEM SARS-COV-2 REAGENT KIT QJR BECTON, DICKINSON & CO. (SPARKS) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown