BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SARS-COV-2 REAGENTS FOR BD MAX SYSTEM

    MDR report key: 10678356 · Received October 14, 2020

    Report

    Report Number
    1119779-2020-00721
    Event Type
    Malfunction
    Date Received
    October 14, 2020
    Date of Event
    September 24, 2020
    Report Date
    January 18, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    QJR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    EUA#: (B)(4). H6: INVESTIGATION SUMMARY: THE COMPLAINT INVESTIGATION FOR DISCREPANT (FALSE POSITIVE), UNRESOLVED (UNR) AND INDETERMINATE (IND) RESULTS WHEN USING THE BD MAX SARS-COV-2 REAGENTS (REF# 44500301) LOTS 0154887, 0160157 & 0168215 WAS PERFORMED BY THE REVIEW OF THE MANUFACTURING RECORDS, ANALYSIS OF THE CUSTOMER¿S DATA AND VERIFICATION OF COMPLAINTS HISTORY. THE COMPLAINT WAS OPENED ON BD MAX SARS-COV-2 REAGENTS LOT 0168467, BUT THIS LOT NUMBER DOES NOT CORRESPOND TO A BD MAX SARS COV-2 REAGENT LOT. THE INVESTIGATION WAS PERFORMED ON THE BD MAX SARS-COV-2 REAGENTS KITS USED WITH THE CUSTOMER IDENTIFIED SAMPLES. REVIEW OF THE MANUFACTURING RECORDS OF BD MAX SARS-COV-2 REAGENTS LOTS 0154887, 0160157 & 0168215 INDICATED THAT THESE LOTS WERE MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER PROVIDED THE DATABASE FROM INSTRUMENT CT1760 FOR INVESTIGATION. AMONG THE 1243 SAMPLES TESTED ON THE DATABASE PROVIDED, ONLY 30 SAMPLES WERE IMPACTED BY THE CUSTOMER ISSUES. ACCORDING TO THE CUSTOMER THESE SAMPLES GAVE NEGATIVES RESULTS WHEN REPEATED ON THE BD MAX¿ OR WHEN TESTED WITH OTHER METHODS. THE CUSTOMER¿S UDP SETTINGS WERE VERIFIED AND THE RESULT LOGIC PARAMETERS WERE SET IN ACCORDANCE WITH THE BD MAX SARS-COV-2 REAGENTS PACKAGE INSERT INSTRUCTION FOR USE. PCR CURVES ANALYSIS OF THREE UNR RESULTS (RUN 33, A6 / RUN 64, B2 / RUN 70, A8) SHOW UNEXPECTED LOW FLUORESCENCE VALUES IN RAW, NEAR ZERO COMPARED TO THE OTHER SAMPLES IN THE RUNS. UNRESOLVED RESULTS MAY BE OBTAINED IN THE EVENT THAT SPECIMEN-ASSOCIATED INHIBITION OR REAGENT FAILURE PREVENTS PROPER TARGET OR RNASE P AMPLIFICATION. AS RECOMMENDED IN THE PACKAGE INSERT, SUCH UNRESOLVED RESULTS SHOULD BE REPEATED. BASED ON THE AVAILABLE DATA, BD IS UNABLE TO DETERMINE THE EXACT CAUSE FOR THESE UNR. TWO IND RESULTS (RUN 67, B11 & RUN 81, B6) WERE OBTAINED AND WERE CAUSED BY A WARNING READER SATURATION ERROR. WARNING READER SATURATION ERROR IS A KNOWN ISSUE WITH THE PREVIOUS BD SARS COV-2 ASSAY VERSION THAT CORRESPONDS TO THE LOT #¿S IN QUESTION. INDEED, THE HIGH BACKGROUND FLUORESCENCE IS RENDERING THE BD SARS COV2 TEST LESS ROBUST TO NORMAL SYSTEM-INDUCED NOISE. PCR CURVES ANALYSIS OF DISCREPANT RESULTS ALLOWED IDENTIFICATION OF 2 CURVES PROFILES PATTERN. HOWEVER, 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. THE FIRST CURVE PROFILE PATTERN (14 SAMPLES: RUN 9, A1,A7 / RUN 11, B1 / RUN 15, B1 / RUN 18, A12 / RUN 36, A7/ RUN 43, A1 / RUN 45, A3 / RUN 47, A8 / RUN 61, A9, A10 / RUN 75, A5 / RUN 103, A11, B12) CONSIST OF NORMAL PCR AMPLIFICATION CURVES SUGGESTING TRUE AMPLIFICATION FOR N1 OR/AND N2 TARGETS WITHOUT ANOMALY, SUGGESTING A TRUE POSITIVE RESULTS. 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. THE SECOND CURVE PROFILE PATTERN (11 SAMPLES : RUN 6, A12 / RUN 16, B6 / RUN 32, A5 / RUN 47, A9 / RUN 60 , A6 / RUN 61, B12 / RUN 62, A6 / RUN 65, A12 / RUN 83, B2 / RUN 96, A11 / RUN 102, B6) SHOWED A STEP DISLOCATION IN THE RAW PCR SIGNAL AND GENERATED POSITIVE RESULTS. IT IS UNLIKELY THAT THE STEP DISLOCATIONS ARE DUE TO TRUE AMPLIFICATION AND A ROOT CAUSE COULD NOT BE IDENTIFIED. THESE CURVES OCCURRED USING DIFFERENT POSITIONS, PUMPS AND DECKS, THEREFORE, THE INSTRUMENT IS NOT SUSPECTED TO BE IN CAUSE. THERE IS NO INDICATION OF AN INCREASE IN COMPLAINTS FOR DISCREPANT (FALSE POSITIVE), UNRESOLVED (UNR) AND READER SATURATION WARNING (IND) FOR THE BD SARS-COV-2 LOTS 0154887, 0160157 & 0168215. THE ROOT CAUSE FOR THE DISCREPANT RESULT AND UNRESOLVED WAS NOT IDENTIFIED. THE ISSUE OBSERVED FOR THE IND SAMPLES AT THE CUSTOMER SITE WAS PREVIOUSLY IDENTIFIED BY BD. A CORRECTIVE AND PREVENTIVE ACTION (CAPA) 1632720 HAS ALREADY BEEN OPEN TO INVESTIGATE THE SYSTEM INDUCED READER SATURATION EVENTS AND THE INVESTIGATION IDENTIFIED THE ROOT CAUSE AS HIGHER BACKGROUND FLUORESCENCE. THE LOT NUMBERS MENTIONED IN THE COMPLAINT INDICATES THAT THE CUSTOMER IS RUNNING A VERSION OF THE ASSAY THAT DOES NOT CONTAIN THE IMPROVEMENTS PRESENTED IN THE CAPA AND THIS VERSION IS NO LONGER MANUFACTURED. THIS ISSUE HAS BEEN REMEDIATED IN THE AMENDED VERSION OF THE ASSAY. BD DID NOT INITIATE A CORRECTIVE AND PREVENTIVE ACTION (CAPA) FOR THE OTHER SAMPLES. BD CONFIRMS THE COMPLAINT ONLY FOR THE IND SAMPLES BASED ON THE INVESTIGATION THAT WAS PERFORMED. BD CANNOT CONFIRM THE COMPLAINT FOR THE OTHER SAMPLES. H3 OTHER TEXT : SEE H.10.

    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 CUSTOMER REPEATED TESTS WITH TWO OTHER PCR SYSTEMS AND THE RESULTS WERE NEGATIVE. FALSE POSITIVE RESULTS WERE NOT REPORTED OUT, AND HERE WAS NO REPORT OF PATIENT IMAPACT. EUA#: (B)(4).

    Additional Manufacturer Narrative · 1

    EUA# (B)(4). MEDICAL DEVICE LOT #: 0168467 WAS REPORTED, HOWEVER, THIS IS NOT A LOT# MANUFACTURED FOR THIS PRODUCT. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).

    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 CUSTOMER REPEATED TESTS WITH TWO OTHER PCR SYSTEMS AND THE RESULTS WERE NEGATIVE. FALSE POSITIVE RESULTS WERE NOT REPORTED OUT, AND HERE WAS NO REPORT OF PATIENT IMPACT. EUA# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1146346 BD SARS-COV-2 REAGENTS FOR BD MAX SYSTEM SARS-COV-2 REAGENT KIT QJR BECTON, DICKINSON & CO. (SPARKS) SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other