BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 11780781 · Received May 5, 2021

    Report

    Report Number
    1119779-2021-00772
    Event Type
    Malfunction
    Date Received
    May 5, 2021
    Date of Event
    April 1, 2021
    Report Date
    July 21, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    QJR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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 · 1

    INVESTIGATION: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULT WHEN USING BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM (REF 444213) LOTS K21-206, K21-211 AND K21-224 WAS PERFORMED BY THE REVIEW OF THE MANUFACTURING RECORDS, REVIEW OF CUSTOMERS DATA AND VERIFICATION OF COMPLAINTS HISTORY. DATA ANALYSIS HAS REVEALED THAT BD MAX" EXK" TNA-3 KIT LOT #1039503 WAS USED IN COMBINATION WITH THE BD BIOGX SARS-COV-2 LOTS IDENTIFIED IN THE COMPLAINT. THE INVESTIGATION WAS CONDUCTED BY BD AND BIOGX. THIS KIT OF BD MAX" EXK" TNA-3 LOT WAS THEREFORE INCLUDED IN THE INVESTIGATION. BIOGX REVIEW OF THE QUALITY CONTROL TESTING DATA INDICATES THAT KIT COMPONENTS FOR LOTS K21-206, K21-211 AND K21-224 PERFORM AS EXPECTED AND MEET BIOGX PERFORMANCE CRITERIA. REVIEW OF THE MANUFACTURING RECORDS OF BD MAX EXK TNA-3 INDICATED THAT LOTS #1039503 WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. THE CUSTOMER REPORTED DISCREPANT RESULTS FOR FOUR PATIENTS. THEY OBTAINED POSITIVE RESULTS FOR N1 ON DIFFERENT DATES FOR THE SAME PROVIDER. AS RESULTS WERE QUESTIONED, TWO OUT OF THE FOUR SPECIMENS WERE RECOLLECTED AND REPEATED USING THE BD MAX AND RESULTS WERE NEGATIVE. CUSTOMER PROVIDED FIVE RUN FILES (RUN #(B)(4) FROM INSTRUMENT CT1534 FOR INVESTIGATION. THE CUSTOMERS UDP SETTINGS WERE VERIFIED AND THE RESULT LOGIC PARAMETERS WERE SET IN ACCORDANCE WITH THE BIOGX SARS COV-2 INSTRUCTION FOR USE. MANUAL PCR CURVE ADJUDICATION WAS CONDUCTED ACROSS FOUR SAMPLES MENTIONED IN THE COMPLAINT TEXT: A02/RUN (B)(4), A10/RUN (B)(4), B05/RUN (B)(4) AND B03/RUN (B)(4). 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. ANALYSIS OF PCR CURVES FOR ALL FOUR SAMPLES SHOW LATE BUT TRUE AMPLIFICATION FOR N1 TARGET. OTHER SAMPLES WERE COLLECTED AND TESTED FOR PATIENTS ASSOCIATED WITH A02/RUN (B)(4) AND A10/RUN (B)(4). TESTING WAS PERFORMED ON RUN 1100 WHERE A01 SAMPLE CORRESPOND TO A10/RUN (B)(4) AND A02 TO A02/RUN (B)(4). MANUAL PCR CURVE ADJUDICATION WAS CONDUCTED AND, ALTHOUGH THE STATUS WAS NEGATIVE, A VERY WEAK AMPLIFICATION WAS DETECTABLE IN A01/RUN (B)(4) LANE. NO AMPLIFICATION SIGNAL WAS DETECTABLE FOR LANE A02/RUN (B)(4). 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 CROSS CONTAMINATION INTRODUCED DURING THE SAMPLE PREPARATION AT THE CUSTOMERS SITE. OVERALL, BD WAS UNABLE TO CONFIRM THE EXACT CAUSE OF THE CUSTOMERS POSITIVE RESULTS. THERE IS NO INDICATION OF AN INCREASE IN COMPLAINTS FOR DISCREPANT RESULT FOR BIOGX SARS-COV-2 OSR LOTS K21-206, K21-211 AND K21-224. THE ROOT CAUSE WAS NOT IDENTIFIED. 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 APOLOGIZES FOR THE INCONVENIENCE THAT THIS MAY HAVE CAUSED. BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE TESTING FOR SARS-COV-2 WITH A BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX" SYSTEMA FALSE POSITIVE RESULT WAS OBTAINED. THE CUSTOMER REPORTED 4 PATIENTS WERE TESTED, 2 OF THE PATIENTS WERE RE-SAMPLED AND THE RESULTS WERE NEGATIVE. THERE WAS NO INFORMATION PROVIDED REGARDING THE 2 PATIENTS THAT DID NOT RESUBMIT SAMPLE. THE PATIENT SELF QUARANTINED. EUA# (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (1 OF 4). IT WAS REPORTED THAT FOUR FALSE POSITIVE RESULTS WHILE USING CAT 444213 MULTIPLE LOT ALL POSITIVE RESULTS EXHIBITED REAL AMPLIFICATION THAT WAS CLOSE TO THE LIMIT OF DETECTION. EVEN A REPEAT SAMPLE EXHIBITED LATE AMPLIFICATION ON N1, CONFIRMING IT WAS LIKELY A TRUE LOW POSITIVE. THERE WERE NO APPARENT INSTRUMENT ISSUES OR EVIDENCE OF SIGNIFICANT CONTAMINATION. PER CUSTOMER, FOUR SPECIMENS WERE REPORTED POSITIVE. TWO OF THE SPECIMENS WERE RECOLLECTED PER PROVIDER'S REQUESTS AND THE RESULTS WERE NEGATIVE. INITIAL RESULTS WERE REPORTED TO PATIENTS AND THEY WERE QUARANTINED WHILE WAITING FOR REPEAT RESULT. CUSTOMER COULD NOT PROVIDE ADDITIONAL INFORMATION ABOUT THE TWO PATIENTS THAT DID NOT RESUBMIT A SPECIMEN. SAMPLE #1: RUN #(B)(4), LANE A2, ACCESSION NUMBER (B)(4) ((B)(6) 2021), BIOGX LOT #K21-224. REPEAT SAMPLE: RUN #(B)(4), LANE A2, ACCESSION NUMBER (B)(4) ((B)(6) 2021), BIOGX LOT #K21-211. SAMPLE #2: RUN #(B)(4), LANE A10, ACCESSION NUMBER (B)(4) ((B)(6) 2021), BIOGX LOT #K21-224. REPEAT SAMPLE: RUN #(B)(4), LANE A1, ACCESSION NUMBER (B)(4) ((B)(6) 2021), BIOGX LOT #K21-211. SAMPLE #3: RUN #(B)(4), LANE B5, ACCESSION NUMBER (B)(4) ((B)(6) 2021), BIOGX LOT #K21-211. REPEAT SAMPLE: CLIENT DID NOT RESUBMIT A NEW SAMPLE. SAMPLE #4 WAS PERFORMED ON RUN #(B)(4), LANE B3, ACCESSION NUMBER (B)(4) ((B)(6) 2021), BIOGX LOT #K21-206. REPEAT SAMPLE: CLIENT DID NOT RESUBMIT A NEW SAMPLE. CUSTOMER REPORTS THAT THEY HAD FOUR PATIENTS POSITIVE FOR N1 ON DIFFERENT DATES FOR THE SAME PROVIDER. RESULTS WERE REPORTED TO PATIENTS AND RESULTS WERE QUESTIONED BY BOTH THE PROVIDER AND PATIENTS. TWO OUT OF THE FOUR SPECIMENS WERE RECOLLECTED AND REPEATED USING THE BD MAX AND RESULTS WERE NEGATIVE. CUSTOMER STATES THAT, BETWEEN EACH RUN, THE BD MAX RACKS, INTERIOR OF INSTRUMENT, AND SURROUNDING COUNTERTOPS, KEYBOARDS, PIPETTES, ETC ARE CLEANED WITH 10% BLEACH FOLLOWED WITH WATER. DAILY, THE ROOM (ALL COUNTERS, CABINETS, HANDLES, KEYBOARDS, MICE, ETC&)IS CLEANED WITH CAVI-WIPES AND/OR CHLOROX DISINFECTANT WIPES. EM WERE PERFORMED WITH NO POSITIVE RESULTS. CUSTOMER COULD NOT PROVIDE DATE. NO BUBBLES NOTICED IN PCR CARTRIDGE. ALL SAMPLES ARE NASAL IN VIRAL TRANSPORT MEDIA. CUSTOMER USED 750ULOF THE SAMPLE.

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE TESTING FOR SARS-COV-2 WITH A BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX" SYSTEMA FALSE POSITIVE RESULT WAS OBTAINED. THE CUSTOMER REPORTED 4 PATIENTS WERE TESTED, 2 OF THE PATIENTS WERE RE-SAMPLED AND THE RESULTS WERE NEGATIVE. THERE WAS NO INFORMATION PROVIDED REGARDING THE 2 PATIENTS THAT DID NOT RESUBMIT SAMPLE. THE PATIENT SELF QUARANTINED. EUA# (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (1 OF 4) IT WAS REPORTED THAT FOUR FALSE POSITIVE RESULTS WHILE USING CAT 444213 MULTIPLE LOT ALL POSITIVE RESULTS EXHIBITED REAL AMPLIFICATION THAT WAS CLOSE TO THE LIMIT OF DETECTION. EVEN A REPEAT SAMPLE EXHIBITED LATE AMPLIFICATION ON N1, CONFIRMING IT WAS LIKELY A TRUE LOW POSITIVE. THERE WERE NO APPARENT INSTRUMENT ISSUES OR EVIDENCE OF SIGNIFICANT CONTAMINATION. PER CUSTOMER, FOUR SPECIMENS WERE REPORTED POSITIVE. TWO OF THE SPECIMENS WERE RECOLLECTED PER PROVIDER'S REQUESTS AND THE RESULTS WERE NEGATIVE. INITIAL RESULTS WERE REPORTED TO PATIENTS AND THEY WERE QUARANTINED WHILE WAITING FOR REPEAT RESULT. CUSTOMER COULD NOT PROVIDE ADDITIONAL INFORMATION ABOUT THE TWO PATIENTS THAT DID NOT RESUBMIT A SPECIMEN. SAMPLE #1: RUN #(B)(4), LANE A2, ACCESSION NUMBER (B)(4) ((B)(6) 2021), BIOGX LOT #K21-224, REPEAT SAMPLE: RUN #(B)(4), LANE A2, ACCESSION NUMBER (B)(4) ((B)(6) 2021), BIOGX LOT #K21-211. SAMPLE #2: RUN #(B)(4), LANE A10, ACCESSION NUMBER (B)(4) ((B)(6) 2021), BIOGX LOT #K21-224, REPEAT SAMPLE: RUN #(B)(4), LANE A1, ACCESSION NUMBER (B)(4) ((B)(6) 2021), BIOGX LOT #K21-211 SAMPLE #3: RUN #(B)(4), LANE B5, ACCESSION NUMBER (B)(4) ((B)(6) 2021), BIOGX LOT #K21-211, REPEAT SAMPLE: CLIENT DID NOT RESUBMIT A NEW SAMPLE. SAMPLE #4 WAS PERFORMED ON RUN #(B)(4), LANE B3, ACCESSION NUMBER (B)(4) ((B)(6) 2021), BIOGX LOT #K21-206, REPEAT SAMPLE: CLIENT DID NOT RESUBMIT A NEW SAMPLE. CUSTOMER REPORTS THAT THEY HAD FOUR PATIENTS POSITIVE FOR N1 ON DIFFERENT DATES FOR THE SAME PROVIDER. RESULTS WERE REPORTED TO PATIENTS AND RESULTS WERE QUESTIONED BY BOTH THE PROVIDER AND PATIENTS. TWO OUT OF THE FOUR SPECIMENS WERE RECOLLECTED AND REPEATED USING THE BD MAX AND RESULTS WERE NEGATIVE. CUSTOMER STATES THAT, BETWEEN EACH RUN, THE BD MAX RACKS, INTERIOR OF INSTRUMENT, AND SURROUNDING COUNTERTOPS, KEYBOARDS, PIPETTES, ETC ARE CLEANED WITH 10% BLEACH FOLLOWED WITH WATER. DAILY, THE ROOM (ALL COUNTERS, CABINETS, HANDLES, KEYBOARDS, MICE, ETC&) IS CLEANED WITH CAVI-WIPES AND/OR CHLOROX DISINFECTANT WIPES. EM WERE PERFORMED WITH NO POSITIVE RESULTS. CUSTOMER COULD NOT PROVIDE DATE. NO BUBBLES NOTICED IN PCR CARTRIDGE. ALL SAMPLES ARE NASAL IN VIRAL TRANSPORT MEDIA. CUSTOMER USED 750ULOF THE SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677170 IOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM SARS-COV-2 REAGENT KIT QJR BECTON, DICKINSON & CO. (SPARKS) K21-224

    Patients

    Seq Age Sex Outcome Treatment
    1