BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 11842213 · Received May 18, 2021

    Report

    Report Number
    1119779-2021-00847
    Event Type
    Malfunction
    Date Received
    May 18, 2021
    Date of Event
    April 26, 2021
    Report Date
    July 13, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    QJR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    EUA# (B)(4). MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR ADDITIONAL LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: K21-244. MEDICAL DEVICE EXPIRATION DATE: 2021-09-19. DEVICE MANUFACTURE DATE: 2021-03-30. 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 FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: MEDICAL DEVICE LOT #: K21-196. MEDICAL DEVICE EXPIRATION DATE: 9/3/2021. DEVICE MANUFACTURE DATE: 3/10/2021. MEDICAL DEVICE LOT #: K21-244. MEDICAL DEVICE EXPIRATION DATE: 9/19/2021. DEVICE MANUFACTURE DATE: 3/30/2021. INVESTIGATION: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULT WHEN USING BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM (REF 444213) LOTS K21-196 AND K21-244 IN COMBINATION WITH THE BD MAX¿ EXK¿ TNA-3 (442827) LOTS #1039503 AND #1068097 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 BD MAX EXK TNA-3 INDICATED THAT LOTS #1039503 AND #1068097 WERE MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. BIOGX REVIEW OF THE QUALITY CONTROL TESTING DATA INDICATES THAT BOTH KIT COMPONENT FOR BIOGX LOTS K21-196 AND K21-244 PERFORM AS EXPECTED AND MEET BIOGX PERFORMANCE CRITERIA. CUSTOMER REPORTED THREE DIFFERENT PATIENT SAMPLES ON ONE RUN THAT WERE COV-2 POSITIVE THAT SUBSEQUENTLY TESTED NEGATIVE BY ANOTHER PCR TEST, AS WELL AS WHEN REPEATED ON THE BD MAX. CUSTOMER PROVIDED FOUR RUNS FILE CONTAINING DATA FROM 68 SAMPLES. THE CUSTOMER¿S UDP SETTINGS WERE VERIFIED. ACCORDING TO THE LATEST BIOGX SARS COV-2 INSTRUCTION FOR USE, THE MASTER MIX FORMAT SETTING SHOULD BE SETTLED TO DUAL MASTER MIX: LYOPHILIZED MM WITH REHYDRATION BUFFER (TYPE 4). NEVERTHELESS, THE CUSTOMER UDP MASTER MIX FORMAT SETTING IS SETTLED TO DUAL MASTER MIX: DRIED MM WITH PRIMERS AND PROBES. THIS DISCREPANCY BETWEEN SETTINGS IS CONSIDERED AS AN OFF-LABEL USE OF THE PRODUCT. CUSTOMER SHOULD ADJUST UDP WITH CORRECT SETTINGS TO ENSURE PROPER PERFORMANCE OF THE ASSAY. NONETHELESS, THE DATA WERE ANALYZED BY MANUAL PCR CURVE ADJUDICATION. 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. FOR PATIENT #1 (SAMPLES (B)(6)), THE PCR CURVE PATTERN IN RUN #6414, LANE A03 (N1 POS) SHOWS MULTIPLE STEP DISLOCATIONS IN THE PCR SIGNAL WHICH GENERATED A POSITIVE RESULT. IT IS UNLIKELY THAT STEP DISLOCATIONS ARE DUE TO TRUE AMPLIFICATION AND A ROOT CAUSE COULD NOT BE IDENTIFIED. FOR PATIENT #2 (SAMPLES (B)(6)) THE PCR CURVE PATTERN IN RUN #6414, LANE B07 SHOWS LATE CT VALUES AND WEAK AMPLIFICATION OF THE N1 TARGET, COMBINED WITH STRONG RNASEP AMPLIFICATION, WHICH IS CHARACTERISTIC OF LOW BUT TRUE POSITIVE SAMPLES. SUCH 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. SAMPLES AT ASSAY LOD CAN HAVE VARIABLE RESULTS UPON REPEAT WHICH COULD EXPLAIN THE SUBSEQUENT NEGATIVE RESULTS (RUN #6428 LANE A11 AND RUN #6416 LANE B06). MOREOVER, LIMIT OF DETECTION CAN VARY BETWEEN DIFFERENT ASSAYS. FOR PATIENT #3 (SAMPLES (B)(6)), THE PCR CURVE PATTERN FOR RUN #6414, LANE A08, TESTED WITH KIT LOT #1039503, SHOWS LATE CT VALUES AND WEAK AMPLIFICATION OF THE N1 TARGET, COMBINED WITH STRONG RNASEP AMPLIFICATION, WHICH IS CHARACTERISTIC OF LOW POSITIVE SAMPLES. THE SAME SAMPLE WAS RETESTED USING KIT LOT #1068097, AND AGAIN DISPLAYED LATE CT VALUES FOR N1 AND N2 TARGETS, FURTHER SUPPORTING POSSIBLE SAMPLES AT OR NEAR THE LOD OF THE ASSAY. SAMPLES AT ASSAY LOD CAN HAVE VARIABLE RESULTS UPON REPEAT WHICH COULD EXPLAIN THE SUBSEQUENT NEGATIVE RESULTS (RUN #6429 LANE B12, SAMPLE (B)(6) TESTED USING KIT LOT #1068097). FURTHERMORE, CUSTOMER DID NOT USE THE RECOMMENDED UDP SETTINGS FOR THE THREE PATIENT SAMPLES. THE MASTER MIX FORMAT SETTING MIGHT, IN SOME CASES, INFLUENCE ASSAY LOD. THEREFORE, BD RECOMMENDS USING THE UDP SETTINGS AS PRESCRIBED IN THE PACKAGE INSERT TO OPTIMIZE ASSAY PERFORMANCE. OVERALL, BD WAS UNABLE TO CONFIRM THE EXACT CAUSE OF THE CUSTOMER¿S POSITIVE RESULTS. THERE IS NO INDICATION OF AN INCREASE IN COMPLAINTS FOR DISCREPANT RESULT FOR BIOGX SARS-COV-2 OSR LOTS K21-196 AND K21-244. THE ROOT CAUSE WAS NOT IDENTIFIED FOR PATIENT #1, POSITIVE SAMPLES AT THE LIMIT OF DETECTION OF THE ASSAY AND/OR CONTAMINATION BY CUSTOMERS ARE SUSPECTED OF PATIENTS #2 AND #3. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. BD & BIOGX PRODUCT MANUFACTURER DID NOT INITIATE A CORRECTIVE AND PREVENTIVE ACTION (CAPA). BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS.

    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. SAMPLE WAS REPEATED AND WAS AGAIN POSITIVE. SAMPLE WAS RECOLLECTED AND CONFIRMATORY ALTERNATE PCR TEST METHOD AND ALSO WITH BIOGX AND THE RESULTS WERE NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT. EUA# (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (PATIENT 3 OF 3). CUSTOMER HAD THREE DIFFERENT PATIENT SAMPLES ON ONE RUN THAT WERE COV-2 POSITIVE THAT SUBSEQUENTLY TESTED AS NEGATIVE BY ANOTHER PCR TEST AND ALSO WHEN REPEATED ON THE BD MAX. THE THREE PATIENT SAMPLES, WERE ALL INITIALLY PERFORMED ON THE SAME RUN ON (B)(6) 2021 WITH THE BIOGX COV-2 ASSAY LOT# K21-196 TNA KIT LOT# 1039503. TWO OF THE THREE PATIENT SAMPLES WERE REPEATED (NEW SPECIMENS COLLECTED) AND WERE SUBSEQUENTLY NEGATIVE ON THE CEPHEID. THE PATIENTS WERE REPEATED ON THE BD MAX AND THE RESULTS WERE NEGATIVE. THE REPEATS ON TWO OF THE THREE SAMPLES WAS PERFORMED AT THE REQUEST OF THE PROVIDER. THE THIRD PATIENT WAS ALSO REPEATED (SAME SAMPLE) AND THE RESULT WAS AGAIN POSITIVE (N1 AND N2). A NEW SAMPLE WAS COLLECTED FROM PATIENT #3 AND THE RESULT WAS NEGATIVE ON THE BIOGX ASSAY AND BY THE BIOFIRE (CUSTOMER HAS MULTIPLE ASSAY PLATFORMS INCLUDING CEPHEID AND BIOFIRE). CUSTOMER ALSO MOVED TO A DIFFERENT LOT# OF THE BIOGX ASSAY LOT# K21-244 TNA KIT LOT# 668097. VTM IS THE COLLECTION AND TRANSPORT MEDIA BEING USED FOR SAMPLE COLLECTION. ALL THREE PATIENTS WERE ASYMPTOMATIC IN-PATIENTS GETTING ROUTINELY TESTED FOR DISCHARGE TO LONG-TERM NURSING FACILITIES. CUSTOMER ALSO CONFIRMED NO ISSUES WITH EXTERNAL QUALITY CONTROL. ENVIRONMENTAL TESTING WAS PERFORMED ON (B)(6) 2021 (ALL SITES TESTED AS NEGATIVE).

    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. SAMPLE WAS REPEATED AND WAS AGAIN POSITIVE. SAMPLE WAS RECOLLECTED AND CONFIRMATORY ALTERNATE PCR TEST METHOD AND ALSO WITH BIOGX AND THE RESULTS WERE NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT. EUA# (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (PATIENT 3 OF 3). CUSTOMER HAD THREE DIFFERENT PATIENT SAMPLES ON ONE RUN THAT WERE COV-2 POSITIVE THAT SUBSEQUENTLY TESTED AS NEGATIVE BY ANOTHER PCR TEST AND ALSO WHEN REPEATED ON THE BD MAX. THE THREE PATIENT SAMPLES, WERE ALL INITIALLY PERFORMED ON THE SAME RUN ON (B)(6) 2021 WITH THE BIOGX COV-2 ASSAY LOT# K21-196 TNA KIT LOT# 1039503. TWO OF THE THREE PATIENT SAMPLES WERE REPEATED (NEW SPECIMENS COLLECTED) AND WERE SUBSEQUENTLY NEGATIVE ON THE CEPHEID. THE PATIENTS WERE REPEATED ON THE BD MAX AND THE RESULTS WERE NEGATIVE. THE REPEATS ON TWO OF THE THREE SAMPLES WAS PERFORMED AT THE REQUEST OF THE PROVIDER. THE THIRD PATIENT WAS ALSO REPEATED (SAME SAMPLE) AND THE RESULT WAS AGAIN POSITIVE (N1 AND N2). A NEW SAMPLE WAS COLLECTED FROM PATIENT #3 AND THE RESULT WAS NEGATIVE ON THE BIOGX ASSAY AND BY THE BIOFIRE (CUSTOMER HAS MULTIPLE ASSAY PLATFORMS INCLUDING CEPHEID AND BIOFIRE). CUSTOMER ALSO MOVED TO A DIFFERENT LOT# OF THE BIOGX ASSAY LOT# K21-244 TNA KIT LOT# 668097. VTM IS THE COLLECTION AND TRANSPORT MEDIA BEING USED FOR SAMPLE COLLECTION. ALL THREE PATIENTS WERE ASYMPTOMATIC IN-PATIENTS GETTING ROUTINELY TESTED FOR DISCHARGE TO LONG-TERM NURSING FACILITIES. CUSTOMER ALSO CONFIRMED NO ISSUES WITH EXTERNAL QUALITY CONTROL. ENVIRONMENTAL TESTING WAS PERFORMED ON 4/26/21 (ALL SITES TESTED AS NEGATIVE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737155 BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM SARS-COV-2 QJR BECTON, DICKINSON & CO. (SPARKS) SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1