BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SARS-COV-2 REAGENTS FOR BD MAX SYSTEM

    MDR report key: 10367456 · Received August 5, 2020

    Report

    Report Number
    1119779-2020-00259
    Event Type
    Malfunction
    Date Received
    August 5, 2020
    Date of Event
    July 9, 2020
    Report Date
    October 5, 2020
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    QJR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO 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 #: 0100380. D.4. MEDICAL DEVICE EXPIRATION DATE: 2020-10-10. H.4. DEVICE MANUFACTURE DATE: 2020-04-09. D.4. MEDICAL DEVICE LOT #: 0100384. D.4. MEDICAL DEVICE EXPIRATION DATE: 2020-10-10. H.4. DEVICE MANUFACTURE DATE: 2020-04-09. D.4. MEDICAL DEVICE LOT #: 0120606. D.4. MEDICAL DEVICE EXPIRATION DATE: 2020-10-30. H.4. DEVICE MANUFACTURE DATE: 2020-04-29. D.4. MEDICAL DEVICE LOT #: 0120611. D.4. MEDICAL DEVICE EXPIRATION DATE: 2020-10-30. H.4. DEVICE MANUFACTURE DATE: 2020-04-29. D.4. MEDICAL DEVICE LOT #: 0120617. D.4. MEDICAL DEVICE EXPIRATION DATE: 2020-10-30. H.4. DEVICE MANUFACTURE DATE: 2020-04-29. D.4. MEDICAL DEVICE LOT #: 0121409. D.4. MEDICAL DEVICE EXPIRATION DATE: 2020-10-31. H.4. DEVICE MANUFACTURE DATE: 2020-04-30. H.6. INVESTIGATION SUMMARY: THE COMPLAINT INVESTIGATION FOR FALSE POSITIVE RESULTS WHEN USING KITS BD MAX SARS-COV-2 REAGENTS (REF 445003) ASSAY LOTS 0100380, 0100384, 0120606, 0120611, 0120617 & 0121409 WAS PERFORMED BY THE REVIEW OF THE MANUFACTURING RECORDS, REVIEW OF THE CUSTOMER DATA AND VERIFICATION OF COMPLAINTS HISTORY. WITH THE RUNS PROVIDED BY THE CUSTOMER, BD FOUND THE FIVE LOTS OF BD MAX EXK TNA-3 AND THE SIX LOTS OF BD SARS-COV-2 REAGENTS FOR BD MAX USED. REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED ON THE BD MAX¿ EXK¿ TNA-3 KIT LOTS 0091427, 0091442, 0128082, 0128088 & 0146935 AND THE RECORDS INDICATED THAT THE QC RESULTS PASSED THE REQUIREMENT FOR RELEASE AND USE. REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED ON THE BD SARS-COV-2 REAGENTS KIT LOTS 0100380, 0100384, 0120606, 0120611, 0120617 & 0121409 AND ALL RESULTS WERE AS EXPECTED. CUSTOMER MENTIONED HAVING A HIGH RATE OF POSITIVE RESULTS WITH A LOW LEVEL OF FLUORESCENCE AND ATYPICAL CURVES WITH BD SARS-COV-2 REAGENT. CUSTOMER PROVIDED 11 RUNS FILES. AS FOR THE SUSPECTED FALSE POSITIVE RESULTS, THEY CAN BE DIVIDED IN THREE CATEGORIES: GLITCHES, ATYPICAL CURVES AND REAL LOW POSITIVE AMPLIFICATIONS. FIRST, THE GLITCHES CATEGORY WAS OBTAINED ON ONE SAMPLE (RUN #447 POSITION A10), THE POTENTIAL CAUSE COULD BE BUBBLES IN THE CARTRIDGE WELL. INDEED, PRESENCE OF 175 L TIPS IN THE BD MAX¿ EXK TNA-3 KIT USED BY THE CUSTOMER COULD HAVE CONTRIBUTED TO THE PRESENCE OF BUBBLES. DESPITE THE GLITCHE, THE AMPLIFICATION CURVE SEEMS TO BE A TRUE BUT LATE AND LOW POSITIVE SAMPLE, THAT COULD BE ALSO AT THE LIMIT OF DETECTION OF THE ASSAY. SECONDLY, THE ATYPICAL CURVES WERE OBTAINED ON FOUR SAMPLES (RUN #532 POSITION A05, RUN #546 POSITION A09, RUN #553 POSITIONS A10 & A11), THE CURVES SHOW NON SIGMOIDAL AMPLIFICATION CURVES, WHICH ARE NOT TRUE AMPLIFICATION. THOSE POSITIVE RESULTS ARISE FROM HIGH GENERAL BACKGROUND IN BOTH FAM (N1 TARGET) AND CY5 (N2 TARGET) CHANNELS, CAUSING AN INTERRUPTION IN BACKGROUND CORRECTION, GENERATING INCREASE OF FLUORESCENCE IN THE CURVES. FINALLY, LOW POSITIVE AMPLIFICATION WERE OBTAINED ON 14 SAMPLES (RUN #447 POSITIONS B03,B05 & B08, RUN #449 POSITION B02, RUN #453 POSITIONS B04, B05 & B10, RUN #484, POSITIONS A08 & B06, RUN #544, POSITION B12, RUN #553, POSITION A04, RUN #555 POSITION A06, RUN #565 POSITION A02 & RUN #576 POSITION A10) AND THE CURVES SHOW A FLUORESCENCE INCREASE AT A LATE CT (>30) WITH A LOW ENDPOINT (<1000) BUT THE CURVES SUGGEST TRUE AMPLIFICATION. THE POTENTIAL CAUSE COULD BE SAMPLE CROSS CONTAMINATION BECAUSE CUSTOMER HAS TESTED POSITIVE PATIENT SAMPLES ALONGSIDE THE SUSPECTED SAMPLES. BD RUNS ANALYSIS ALSO REVEALED CROSSTALK SIGNAL IN ALL THE RUNS EXAMINED, HOWEVER THIS CROSSTALK IS NOT RESPONSIBLE FOR ANY FALSE POSITIVE RESULTS IN THE RUN FILES RECEIVED BUT AN INSTRUMENT VERIFICATION IS RECOMMENDED. THERE IS A COMPLAINT TREND FOR FALSE POSITIVE RESULTS ON KITS BD MAX SARS-COV-2 REAGENTS. THE ROOT CAUSE FOR THE FALSE POSITIVE RESULTS WERE NOT IDENTIFIED. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED BUT A CORRECTIVE AND PREVENTIVE ACTION (CAPA) 1177233 WAS INITIATED TO INVESTIGATE THE ROOT CAUSE OF THE HIGH BACKGROUND FLUORESCENCE VALUES AND SOME MITIGATION ACTIONS ARE ALREADY IN PROCESS. IN ADDITION TO THAT A CORRECTIVE AND PREVENTIVE ACTION IS ALREADY INITIATED TO INVESTIGATE THE 175 L TIPS CONTRIBUTION. EUA #: EUA(B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM A HIGH LEVEL OF FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. THE CURVES APPEARED IRREGULAR, AND SAMPLES WERE REPEATED. ERRONEOUS RESULTS WERE NOT REPORTED OUT, AND THERE WAS NO REPORT OF PATIENT IMPACT. EUA #: 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. (B)(4). MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0146935. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. MEDICAL DEVICE LOT #: 0128088. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. MEDICAL DEVICE LOT #: 0091427. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM A HIGH LEVEL OF FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. THE CURVES APPEARED IRREGULAR, AND SAMPLES WERE REPEATED. ERRONEOUS RESULTS WERE NOT REPORTED OUT, AND THERE WAS NO REPORT OF PATIENT IMPACT. EUA #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    831000 BD SARS-COV-2 REAGENTS FOR BD MAX SYSTEM SARS-COV-2 REAGENT KIT QJR BECTON, DICKINSON & CO. SEE H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other