BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 12550192 · Received September 29, 2021

    Report

    Report Number
    1119779-2021-01593
    Event Type
    Malfunction
    Date Received
    September 29, 2021
    Date of Event
    August 24, 2021
    Report Date
    November 17, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    QJR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    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 44500301) LOT 1120342 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 1120342 WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER COMPLAINED ABOUT LOW N1 POSITIVE / N2 NEGATIVE RESULTS ON SOME NEGATIVE EXTERNAL CONTROLS AND PATIENT SAMPLES WITH THE BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM KIT LOT 1120342, WHICH GAVE A NEGATIVE RESULT UPON REPEAT. CUSTOMER PROVIDED SEVEN RUN FILES (RUNS (B)(4) FROM INSTRUMENT CT1689 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 ALL SUSPECTED FALSE POSITIVE RESULTS IN WHICH ONLY THE N1 TARGET WAS DETECTED, WHILE USING LOT 1120342. THE MANUAL PCR CURVES ADJUDICATION ANALYSIS REVEALED LATE AND LOW, BUT TRUE N1 POSITIVE RESULT. 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. NO REPEAT TEST WAS FOUND FOR THESE SAMPLES. BASED ON THE DATA AND INFORMATION PROVIDED, SPECIMENS AT OR NEAR THE ASSAY LIMIT OF DETECTION (LOD) OR ENVIRONMENTAL OR CROSS CONTAMINATION ARE THE MOST LIKELY CAUSES TO EXPLAIN THE CUSTOMER¿S POSITIVE RESULTS. HOWEVER, BD WAS UNABLE TO CONFIRM THE EXACT CAUSE OF THE CUSTOMER¿S POSITIVE RESULTS, BUT NO REAGENTS 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 1120342. 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).

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING FOR SARS COV-2 A FALSE POSITIVE RESULT WAS OBTAINED. A REPEAT TEST WAS PERFORMED USING AN UNSPECIFIED METHOD AND THE RESULT WAS NEGATIVE. THE CUSTOMER STATED RESULTS WERE NOT REPORTED OUT SO THERE WAS NO REPORT OF PATIENT IMPACT. EUA #: (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " IT WAS REPORTED THAT LOW POSITIVE SIGNALS FOR N1 IN OF THEIR NEGATIVE EXTERNAL CONTROLS AND SAMPLES WITH THE SARS-COV-2 ASSAY. "

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING FOR SARS COV-2 A FALSE POSITIVE RESULT WAS OBTAINED. A REPEAT TEST WAS PERFORMED USING AN UNSPECIFIED METHOD AND THE RESULT WAS NEGATIVE. THE CUSTOMER STATED RESULTS WERE NOT REPORTED OUT SO THERE WAS NO REPORT OF PATIENT IMPACT. (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " IT WAS REPORTED THAT LOW POSITIVE SIGNALS FOR N1 IN OF THEIR NEGATIVE EXTERNAL CONTROLS AND SAMPLES WITH THE SARS-COV-2 ASSAY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1444549 BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM SARS-COV-2 REAGENT KIT QJR BECTON, DICKINSON & CO. (SPARKS) 112034

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown