BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 12292030 · Received August 6, 2021

    Report

    Report Number
    1119779-2021-01324
    Event Type
    Malfunction
    Date Received
    August 6, 2021
    Date of Event
    July 13, 2021
    Report Date
    October 25, 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

    INVESTIGATION SUMMARY: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WHEN USING THE BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM KIT (REF (B)(4)) LOT 1103365 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 1103365 WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER REPORTED FOUR N1 POSITIVE RESULTS WITH THE BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM KIT LOT 1103365 WHICH GAVE A NEGATIVE RESULT UPON REPEAT ON ANOTHER ASSAY. CUSTOMER PROVIDED THREE RUN FILES (6039, 6040 AND 6041) FROM INSTRUMENT CM0045 FOR INVESTIGATION. THE CUSTOMER¿S UDP SETTINGS WERE VERIFIED, AND THE RESULT LOGIC PARAMETERS WERE SET IN ACCORDANCE WITH THE BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM INSTRUCTION FOR USE. MANUAL PCR CURVE ADJUDICATION WAS PERFORMED ACROSS THE FOUR POSITIVE N1 SAMPLES PRESENT IN THE THREE RUNS RECEIVED (RUN 6039 B12, RUN 6040 B1, RUN 6041 A3 AND A4). ANALYSIS OF PCR CURVES REVEALED LATE AND WEAK BUT TRUE AMPLIFICATION. DESPITE A MENTION OF UNUSUAL RNASEP CURVES (FLATTENED, INCREASED SLOPE, FLUCTUATING) IN THE COMPLAINT TEXT, ANALYSIS OF THE CORRESPONDING RNASEP CURVES DID NOT SHOW ANY ANOMALY, WITH ADEQUATE AMPLIFICATION, FOR ALL FOUR SAMPLES. BD WAS THUS UNABLE TO IDENTIFY NOR CONFIRM THE RNASEP UNUSUAL CURVES DESCRIBED BY THE CUSTOMER. OVERALL, SUCH 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 AND THESE ARE THE MOST LIKELY CAUSES TO EXPLAIN THE CUSTOMER¿S POSITIVE RESULTS. MOREOVER, LIMIT OF DETECTION CAN VARY BETWEEN DIFFERENT ASSAYS. NEVERTHELESS, MANUAL CURVE ADJUDICATION HAS LIMITATIONS; VISUAL EXAMINATION OF PCR CURVES FOR LOW SIGNAL IS A CONSERVATIVE ASSESSMENT OF THE DATA. NO REPEAT TEST WAS FOUND FOR THESE SAMPLES. COMPLAINT TEXT ALSO MENTIONED THAT THE LOW N1 POSITIVE SAMPLES WERE REPEATED ON THE GENEXPERT TEST (CEPHEID). CONSIDERING THAT THIS OTHER ASSAY ONLY DETECTS THE N2 AND E GENE TARGETS, AND DOES NOT DETECT THE N1 TARGET, THE CUSTOMER CANNOT CONFIRM THE N1 POSITIVE RESULTS OBTAINED WITH THE BD SARS-COV-2 REAGENT ASSAY WITH THIS OTHER TEST. OVERALL, THE ANALYSIS STRONGLY SUGGESTS TRUE LOW POSITIVE RESULTS. 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 1103365. THE ROOT CAUSE WAS NOT IDENTIFIED. NOTE THAT POSITIVES SAMPLES AT THE LIMIT OF DETECTION OF THE ASSAY OR A THROUGH ENVIRONMENTAL OR CROSS CONTAMINATION INTRODUCED DURING THE SAMPLE PREPARATION AT THE CUSTOMER¿S SITE CAN EXPLAIN THE CUSTOMER DISCREPANT SAMPLES. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. BD DID NOT INITIATE A CORRECTIVE AND PREVENTIVE ACTION (CAPA). H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING FOR SARS COV-2 FALSE POSITIVE RESULTS WERE OBTAINED. REPEAT TESTS WERE PERFORMED USING CEPHEID AND THE RESULTS WERE NEGATIVE. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. EUA #: (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SLIGHTLY POSITIVE RESULTS IN THE N1 GEN."

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE TESTING FOR SARS COV-2 FALSE POSITIVE RESULTS WERE OBTAINED. REPEAT TESTS WERE PERFORMED USING CEPHEID AND THE RESULTS WERE NEGATIVE. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SLIGHTLY POSITIVE RESULTS IN THE N1 GEN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1185644 BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM SARS-COV-2 REAGENT KIT QJR BECTON, DICKINSON & CO. (SPARKS) 1103365

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown