BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 13081772 · Received December 23, 2021

    Report

    Report Number
    1119779-2021-02034
    Event Type
    Malfunction
    Date Received
    December 23, 2021
    Date of Event
    November 30, 2021
    Report Date
    February 11, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    QJR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WHEN USING THE BD SARS-COV-2 REAGENTS KIT LOTS 1279086 AND 1120372 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 INDICATED THAT LOTS 1279086 AND 1120372 WERE MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER REPORTED SUSPECTED FALSE POSITIVE SAMPLES WITH BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM KIT LOT 1279086 WHICH WERE NEGATIVE UPON REPEAT. MOREOVER, KIT LOT 1120372 WAS ALSO USED IN DATA RECEIVED AND WAS INCLUDED IN THE INVESTIGATION. THE SAMPLES WERE POSITIVE ONLY FOR THE N1 TARGET. CUSTOMER PROVIDED SIX RUNS (RUN 109, 111, 117, 118, 125 AND 126) FOR INVESTIGATION. THE CUSTOMER¿S UDP SETTINGS WERE VERIFIED, AND THE RESULT LOGIC PARAMETERS WERE SET IN ACCORDANCE WITH THE BD SARS-COV-2 REAGENT¿S INSTRUCTION FOR USE, EXCEPT FOR THE N2 THRESHOLD WHICH SHOULD BE SET TO 80 INSTEAD OF 50. HOWEVER, THIS CHANGE IN THRESHOLD SETTING DID NOT IMPACT IN THE CUSTOMER RESULTS. NONETHELESS, BD RECOMMENDS THAT THE SETTINGS BE SET IN ACCORDANCE WITH THOSE STATED IN THE ASSAY PACKAGE INSERT. NO SPECIFIC SAMPLES ARE DESCRIBED IN THE COMPLAINT TEXT, BUT SIX RUNS WERE SENT WITH A FOOTNOTE FOR ALL POSITIVE SAMPLES OF EACH RUN SUSPECTED OF BEING FALSE POSITIVE RESULTS. CUSTOMER MENTIONED HAVING REPEATED THE SAMPLES, HOWEVER NO REPEAT WAS FOUND IN THE RUNS PROVIDED. MANUAL PCR CURVE ADJUDICATION OF ALL POSITIVE SAMPLES WAS PERFORMED. PCR CURVES ANALYSIS REVEALED LATE AND LOW, BUT TRUE AMPLIFICATIONS FOR N1 TARGET WITHOUT ANOMALY INDICATIVE OF 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. NEVERTHELESS, MANUAL CURVE ADJUDICATION HAS LIMITATIONS; VISUAL EXAMINATION OF PCR CURVES FOR LOW SIGNAL IS A CONSERVATIVE ASSESSMENT OF THE DATA. HOWEVER, BD IS UNABLE TO CONFIRM THE EXACT CAUSE OF THE ISSUE. NONETHELESS, NO REAGENTS ISSUE IS SUSPECTED. THERE IS NO INDICATION OF A REAGENT ISSUE BASED ON THE ANALYSIS OF THE COMPLAINTS RECEIVED FOR DISCREPANT RESULTS ON BD SARS-COV-2 REAGENTS KIT LOTS 1279086 AND 1120372. THE ROOT CAUSE WAS NOT IDENTIFIED. HOWEVER, 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) SINCE NO REAGENT ISSUE WAS IDENTIFIED. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    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 · 0

    IT WAS REPORTED WHILE TESTING FOR SARS COV-2 FALSE POSITIVE RESULTS WERE OBTAINED. A REPEAT TEST WAS PERFORMED 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: "THERE ARE POSITIVE RESULTS DETECTED WITH THE N1 PROBE."

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING FOR SARS COV-2 FALSE POSITIVE RESULTS WERE OBTAINED. A REPEAT TEST WAS PERFORMED 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: "THERE ARE POSITIVE RESULTS DETECTED WITH THE N1 PROBE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1971458 BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM SARS-COV-2 REAGENT KIT QJR BECTON, DICKINSON & CO. (SPARKS) 1279086

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown