BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 12476988 · Received September 15, 2021

    Report

    Report Number
    1119779-2021-01523
    Event Type
    Malfunction
    Date Received
    September 15, 2021
    Date of Event
    August 12, 2021
    Report Date
    November 11, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    QJR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WHEN USING THE BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM KIT (REF 44500301) LOT 1120394 WAS PERFORMED BY THE REVIEW OF MANUFACTURING RECORDS, REVIEW OF CUSTOMER¿S DATA AND VERIFICATION OF COMPLAINTS HISTORY. REVIEW OF THE MANUFACTURING RECORDS OF THE BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM INDICATED THAT LOT 1120394 WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER COMPLAINED ABOUT A SAMPLE THAT WAS DETECTED POSITIVE WITH THE BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM KIT LOT 1120394, WITH A CT VALUE OF 36 CYCLES. THE CUSTOMER REPEATED THE SAMPLE, AND THE RESULT WAS NEGATIVE. CUSTOMER PROVIDED SEVEN PRINT SCREEN PICTURES OF FLUORESCENCE CURVES (NEGATIVE AND POSITIVE RESULTS) FOR INVESTIGATION. DESPITE SEVERAL REQUESTS MADE TO RECEIVE ADDITIONAL INFORMATION, NO OTHER DATA WAS PROVIDED. AMONG THE SEVEN-PRINT SCREEN, 3 WERE RELATED TO NEGATIVE RESULTS AND 4 WERE RELATED TO POSITIVE N1 TARGET RESULTS. THE COMPLAINT TEXT DID NOT MENTION FOR WHICH SAMPLE THE CUSTOMER WAS COMPLAINING ABOUT. SINCE NO RUN DATA NOR DATABASE WERE RECEIVED, THE CUSTOMER¿S UDP SETTINGS COULD NOT BE VERIFIED. MANUAL PCR CURVE ADJUDICATION WAS CONDUCTED ON THE FLUORESCENCE CURVES RECEIVED. ONE OF THOSE SAMPLES WAS PRESUMED TO BE THE CUSTOMER¿S SUSPECTED FALSE POSITIVE RESULT, WITH A CT VALUE OF 36. THE MANUAL PCR CURVE ADJUDICATION ANALYSIS OF THE FLUORESCENCE CURVES REVEALED LATE AND LOW, BUT TRUE, N1 POSITIVE RESULTS FOR THE 3 POSITIVE SAMPLES FOR WHICH A FLUORESCENCE CURVE WAS PROVIDED. THE CUSTOMER MENTIONED THAT THE RESULT WAS NEGATIVE AFTER REPEAT. SUCH DISCREPANCY UPON REPEAT CAN BE OBTAINED WITH LOW POSITIVE SAMPLES, WHICH CAN OCCUR DUE TO VIRAL TITERS IN THE SPECIMEN BEING AT OR NEAR THE LIMIT OF DETECTION OF THE ASSAY OR THROUGH ENVIRONMENTAL OR CROSS CONTAMINATION INTRODUCED DURING THE SAMPLE PREPARATION AT THE CUSTOMER¿S SITE. BASED ON THE DATA AND INFORMATION PROVIDED, SPECIMEN AT OR NEAR THE LIMIT OF DETECTION OF THE ASSAY OR ENVIRONMENTAL OR CROSS CONTAMINATION INTRODUCED DURING THE SAMPLE PREPARATION ARE THE MOST LIKELY CAUSES TO EXPLAIN THE CUSTOMER POSITIVE RESULT. HOWEVER, BD WAS UNABLE TO CONFIRM THE EXACT CAUSE OF THE CUSTOMER POSITIVE RESULT. MANUAL CURVE ADJUDICATION HAS LIMITATIONS; VISUAL EXAMINATION OF PCR CURVES FOR LOW SIGNAL IS AN EXTREMELY CONSERVATIVE ASSESSMENT OF THE DATA. NO PRODUCT ISSUE IS SUSPECTED. THERE IS NO INDICATION OF AN INCREASE IN COMPLAINTS FOR DISCREPANT RESULTS FOR THE BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM LOT 1120394. THE ROOT CAUSE WAS NOT IDENTIFIED. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE TESTING FOR SARS-COV-2 WITH THE BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM, A FALSE POSITIVE OF CT VALUE 36 WAS OBTAINED. CONFIRMATORY TESTING WITH A SAMPLE TUBE CAME BACK NEGATIVE. ALL POSITIVE RESULTS WERE REPORTED TO THE HEALTH DEPARTMENT. THERE WAS NO REPORT OF PATIENT IMPACT. EUA# (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: "POSITIVE RESULT, AFTER TESTING WITH THE SAME SAMPLE TUBE NEGATIVE RESULT. THE SAMPLE WAS SENT TO THE HEALTH DEPARTMENT IN THE EVENING WITH A POSITIVE RESULT (CT VALUE 36) AND REPEATED THE NEXT DAY FROM THE SAME SAMPLE TUBE AND CAME OUT NEGATIVE. TYPICALLY, SAMPLES IN THE RANGE OF OVER CT 35 ARE REPEATED ON CEPHEID OR BD MAX AND COME OUT NEGATIVE. EVENING SHIFT HAS NO KNOWLEDGE OF THIS AND REPORTS ALL POSITIVE RESULTS TO THE HEALTH DEPARTMENT. NOT AN ISOLATED CASE, ON AVERAGE ONE OUT OF SIXTY SAMPLES EVERY 2ND DAY (OFTEN A CT VALUE OF OVER 35). IN THIS REGARD SECOND PIR. RUN FILES FOLLOW." "YES, NORMALLY THE CUSTOMER LOOKS AT THE CURVES AND REPEATS ALL SAMPLES THAT HAVE AN ATYPICAL CURVE SHAPE OR A CT VALUE OF OVER 35 BEFORE THEY ARE RELEASED. THE EXCEPTION TO THIS IS THAT THE CURVES AND CT VALUES ARE NOT CHECKED DURING THE EVENING SHIFT AND THESE ARE PASSED ON DIRECTLY. THIS IS BECAUSE THERE IS NO TRAINED PCR TEAM PRESENT ON THE EVENING SHIFT. I CAN'T TELL IF ANY ERRONEOUS RESULTS WERE REPORTED TO THE CLINICIAN. THE CUSTOMER ONLY EXPLAINED THAT THE TEST WAS REPEATED THE NEXT MORNING (RESULT NEGATIVE) BECAUSE THERE WERE INCONSISTENCIES THAT HE DID NOT EXPLAIN FURTHER."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE TESTING FOR SARS-COV-2 WITH THE BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM, A FALSE POSITIVE OF CT VALUE 36 WAS OBTAINED. CONFIRMATORY TESTING WITH A SAMPLE TUBE CAME BACK NEGATIVE. ALL POSITIVE RESULTS WERE REPORTED TO THE HEALTH DEPARTMENT. THERE WAS NO REPORT OF PATIENT IMPACT. EUA# (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: "POSITIVE RESULT, AFTER TESTING WITH THE SAME SAMPLE TUBE NEGATIVE RESULT. THE SAMPLE WAS SENT TO THE HEALTH DEPARTMENT IN THE EVENING WITH A POSITIVE RESULT (CT VALUE 36) AND REPEATED THE NEXT DAY FROM THE SAME SAMPLE TUBE AND CAME OUT NEGATIVE. TYPICALLY, SAMPLES IN THE RANGE OF OVER CT 35 ARE REPEATED ON CEPHEID OR BD MAX AND COME OUT NEGATIVE. EVENING SHIFT HAS NO KNOWLEDGE OF THIS AND REPORTS ALL POSITIVE RESULTS TO THE HEALTH DEPARTMENT. NOT AN ISOLATED CASE, ON AVERAGE ONE OUT OF SIXTY SAMPLES EVERY 2ND DAY (OFTEN A CT VALUE OF OVER 35). IN THIS REGARD SECOND PIR. RUN FILES FOLLOW." "YES, NORMALLY THE CUSTOMER LOOKS AT THE CURVES AND REPEATS ALL SAMPLES THAT HAVE AN ATYPICAL CURVE SHAPE OR A CT VALUE OF OVER 35 BEFORE THEY ARE RELEASED. THE EXCEPTION TO THIS IS THAT THE CURVES AND CT VALUES ARE NOT CHECKED DURING THE EVENING SHIFT AND THESE ARE PASSED ON DIRECTLY. THIS IS BECAUSE THERE IS NO TRAINED PCR TEAM PRESENT ON THE EVENING SHIFT. I CAN'T TELL IF ANY ERRONEOUS RESULTS WERE REPORTED TO THE CLINICIAN. THE CUSTOMER ONLY EXPLAINED THAT THE TEST WAS REPEATED THE NEXT MORNING (RESULT NEGATIVE) BECAUSE THERE WERE INCONSISTENCIES THAT HE DID NOT EXPLAIN FURTHER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1373607 BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM SARS-COV-2 REAGENT KIT QJR BECTON, DICKINSON & CO. (SPARKS) 1120394

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown