BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 12506502 · Received September 21, 2021

    Report

    Report Number
    3006948883-2021-00920
    Event Type
    Malfunction
    Date Received
    September 21, 2021
    Date of Event
    August 6, 2021
    Report Date
    October 21, 2021
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    Product Code
    QJR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING LOT INFORMATION WAS REPORTED AS ADDITIONAL INFORMATION. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 1089062. D.4. MEDICAL DEVICE EXPIRATION DATE: 2021-10-15. H.4. DEVICE MANUFACTURE DATE: 2021-03-30. D.4. MEDICAL DEVICE LOT #: 1075163. D.4. MEDICAL DEVICE EXPIRATION DATE: 2021-10-01. H.4. DEVICE MANUFACTURE DATE: 2021-03-16. D.4. MEDICAL DEVICE LOT #: 1120334. D.4. MEDICAL DEVICE EXPIRATION DATE: 2021-11-05. H.4. DEVICE MANUFACTURE DATE: 2021-04-30. D.4. MEDICAL DEVICE LOT #: 1125568. D.4. MEDICAL DEVICE EXPIRATION DATE: 2021-11-12. H.4. DEVICE MANUFACTURE DATE: 2021-05-05.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WHEN USING THE BD MAX SARS-COV-2 REAGENTS (REF# (B)(4)) LOTS 1075163 AND 1089062 WAS PERFORMED BY THE REVIEW OF THE MANUFACTURING RECORDS, RETAIN MATERIAL TESTING, ANALYSIS OF THE CUSTOMER¿S DATA AND VERIFICATION OF COMPLAINTS HISTORY. ALTHOUGH THE COMPLAINT WAS FILED ON LOTS 1075163, 1089062, 1120334 AND 1125568, CUSTOMER DATA ANALYSIS REVEALED THAT BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM KITS LOTS 1075163 AND 1089062 WERE USED WHEN TESTING SAMPLES FOR WHICH FALSE NEGATIVE RESULTS WAS REPORTED. ONLY THESE TWO LOTS WERE THUS INVESTIGATED IN THIS REPORT. REVIEW OF THE MANUFACTURING RECORDS OF THE BD MAX SARS-COV-2 REAGENTS INDICATED THAT LOTS 1075163 AND 1089062 WERE MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER COMPLAINED ABOUT TWO SAMPLES, FROM A KNOWN SARS-COV-2 POSITIVE PATIENT, WHICH OBTAINED A NEGATIVE RESULT CAUSED BY A FAULTY PUMP WHEN USING BD SARS COV-2 REAGENTS FOR BD MAX¿ SYSTEM KIT LOTS 1075163 AND 1089062. IN BOTH SAMPLES, THE RESULT WAS VALID SINCE THE INTERNAL CONTROL (RNASE P GENE) CORRECTLY AMPLIFIED. NONETHELESS, CUSTOMER QUESTIONS WHY THE STATUS IN BOTH TESTS WAS VALID INSTEAD OF UNRESOLVED. RETAIN MATERIAL OF BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM KIT LOTS 1075163 AND 1089062 WAS TESTED IN NEGATIVE AND POSITIVE. NO FALSE RESULT WAS OBTAINED, AND REAGENTS PERFORMED AS EXPECTED. CUSTOMER PROVIDED THE DATABASE FROM INSTRUMENT CT1901 AS WELL AS A TABLE CONTAINING TEN RUNS ID AND THEIR ASSOCIATED KITS LOTS FOR INVESTIGATION. DATA ANALYSIS SHOW THAT SAMPLE A10 RUN 582 AND SAMPLE B10 RUN 620, IDENTIFIED BY THE CUSTOMER, WERE REPEATED IN SAMPLE A10 RUN 595 AND SAMPLE B12 RUN 622. OF THESE FOUR TESTS OF THE KNOWN POSITIVE PATIENT SAMPLE, THREE WERE TESTED USING PUMP #2 AND GAVE A NEGATIVE RESULT. SAMPLE B12 RUN 622 WAS TESTED USING PUMP #4 AND GAVE A POSITIVE RESULT. MANUAL PCR CURVE ADJUDICATION WAS ALSO CONDUCTED ON SAMPLES A10 RUN 582, A10 RUN 595, B10 RUN 620 AND B12 RUN 622. IT WAS NOTED THAT POSITIONS ASSOCIATED WITH PUMP #2 SHOWED HIGHER INITIAL FLUORESCENCE IN ALL CHANNELS, WHICH IS CONSISTENT WITH A PUMP ISSUE. THESE RESULTS SUGGEST THE PUMP #2 ISSUES ON INSTRUMENT CT1901 ARE LINKED TO THE FALSE NEGATIVE RESULTS DESCRIBED BY THE CUSTOMER FOR THIS COMPLAINT. THE UDP SETTINGS WERE VERIFIED AND FOUND TO BE DIFFERENT FROM THOSE MENTIONED IN THE LATEST VERSION OF THE BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM INSTRUCTION FOR USE (P0255). ENDPOINT THRESHOLD LIMIT FOR N1 AND N2 TARGETS WERE MODIFIED, AS WELL AS OTHER PARAMETERS, INCLUDING MODIFICATIONS TO THE LIQUID LEVEL SENSING WHICH WAS DISABLED. THESE CHANGES IN THE UDP SETTINGS ARE CONSIDERED OFF-LABEL AND COULD CAUSE A LOWER SENSITIVITY OF THE ASSAY (CAUSING N1 AND/OR N2 FALSE NEGATIVE RESULTS), AS WELL AS PREVENT DETECTION OF INCORRECT VOLUME PIPETTED (WITH A DISABLED LIQUID LEVEL SENSING). THE RNASE P INTERNAL EXTRACTION CONTROL SERVES AS CONFIRMATION OF PROPER SAMPLE COLLECTION, WHILE ALSO BEING AN AMPLIFICATION CONTROL. NEITHER OF THESE STEPS WERE IMPACTED BY THE PUMP ISSUE, EXPLAINING THE VALID RESULTS OBTAINED FOR THIS TARGET. BD WAS UNABLE TO CONFIRM THE EXACT CAUSE OF THE CUSTOMER¿S ISSUE (RNASE P POSITIVE RESULT DESPITE A DEFECTIVE PUMP). NONETHELESS, INVESTIGATION REVEALED NO ISSUE WITH BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM LOTS 1075163 AND 1089062. FINALLY, IT WAS ALSO OBSERVED THAT FOUR PATIENT SAMPLES SEEMED TO BE POOLED TOGETHER FOR MOST OF THE TESTS. THIS IS OFF LABEL USE AND COULD NEGATIVELY IMPACT PRODUCT PERFORMANCE. BD RECOMMENDS THAT CUSTOMER USES BD SARS COV-2 REAGENTS FOR BD MAX¿ SYSTEM AS PER PACKAGE INSERT INSTRUCTIONS, TO ENSURE PROPER PERFORMANCE OF THE ASSAY. THERE IS NO INDICATION OF AN INCREASE IN COMPLAINTS FOR DISCREPANT RESULTS FOR BD MAX SARS-COV-2 REAGENTS LOTS 1075163 AND 1089062. THE ROOT CAUSE WAS NOT IDENTIFIED. HOWEVER, SEVERAL MODIFICATIONS TO THE INSTRUCTION IN THE PACKAGE INSERT (OFF LABEL) CAN EXPLAIN THE CUSTOMER¿S DISCREPANT RESULTS. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING FOR SARS COV-2 A FALSE NEGATIVE RESULT WAS OBTAINED BY THE LABORATORY PERSONNEL WHILE TESTING A KNOWN POSITIVE PATIENT. THERE WAS NO REPORT OF PATIENT IMPACT. EUA #: EUA (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " WOLLONGONG HOSPITAL REPORTED A FALSE NEGATIVE RESULT ON A COVID PATIENT SAMPLE ON THEIR BD MAX."

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING FOR SARS COV-2 A FALSE NEGATIVE RESULT WAS OBTAINED BY THE LABORATORY PERSONNEL WHILE TESTING A KNOWN POSITIVE PATIENT. THERE WAS NO REPORT OF PATIENT IMPACT. EUA #: (B)(4) THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "(B)(6)HOSPITAL REPORTED A FALSE NEGATIVE RESULT ON A COVID PATIENT SAMPLE ON THEIR BD MAX."

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. 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 WHILE TESTING FOR SARS COV-2 A FALSE NEGATIVE RESULT WAS OBTAINED BY THE LABORATORY PERSONNEL WHILE TESTING A KNOWN POSITIVE PATIENT. THERE WAS NO REPORT OF PATIENT IMPACT. EUA #: (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "(B)(6) HOSPITAL REPORTED A FALSE NEGATIVE RESULT ON A COVID PATIENT SAMPLE ON THEIR BD MAX.".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1401626 BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM SARS-COV-2 REAGENT KIT QJR BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. SEE H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown