BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 12322108 · Received August 13, 2021

    Report

    Report Number
    1119779-2021-01380
    Event Type
    Malfunction
    Date Received
    August 13, 2021
    Date of Event
    July 28, 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
    WV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D4: MEDICAL DEVICE LOT #: 1120321 D4: MEDICAL DEVICE EXPIRATION DATE: 1120321 H4: DEVICE MANUFACTURE DATE: 2021-04-30 H6: INVESTIGATION SUMMARY: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WHEN USING THE BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM KIT (REF 44500301) LOT 1120321 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 1120321 WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER REPORTED DISCREPANT RESULTS WITH THE BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM. ISSUE OCCURRING WITH SEVERAL DIFFERENT PATIENT SAMPLES. CUSTOMER PROVIDED THE DATABASE FROM INSTRUMENT CT0767 FOR INVESTIGATION, AND THE FOUR RUNS MENTIONED IN THE COMPLAINT TEXT (#2839. 2843 AND 2845) WERE EXTRACTED AND ANALYZED. THE CUSTOMER¿S UDP SETTINGS WERE VERIFIED, AND AN ERROR IN THE COLOR COMPENSATION SETTING WAS DETECTED. THERE IS NO COLOR COMPENSATION IN THE CUSTOMER¿S UDP SETTING WHICH DOES NOT CORRESPOND TO THE RECOMMENDED SETTING OF THE LATEST VERSION OF THE BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM INSTRUCTION FOR USE. HOWEVER, SINCE THE COMPLAINT IS FOR N1 POSITIVE RESULTS (IN THE FAM CHANNEL), THE ERROR IN THE UDP SETTING IS NOT LINKED WITH WHAT IS REPORTED BY THE CUSTOMER (COLOR COMPENSATION IS ASSOCIATED WITH THE N2 TARGET IN THE CY5 CHANNEL). NONETHELESS, IT IS RECOMMENDED THAT CUSTOMER CHANGES PARAMETERS TO ADJUST THE SETTINGS AS DESCRIBED IN THE IFU TO ENSURE PROPER PERFORMANCE OF THE ASSAY. MANUAL PCR CURVE ADJUDICATION WAS PERFORMED. SAMPLES IN RUN #2839 LANES A04 AND A11 WERE COV2 POSITIVE FOR THE N1 TARGET ONLY AND ALL THE OTHER SAMPLES WERE COV2 NEGATIVE. ANALYSIS OF FLUORESCENCE CURVES OF THOSE 2 LANES SHOW A WEAK BUT AMPLIFICATION FOR N1 TARGET. THOSE SAMPLE CURVES LOOK LIKE TRUE BUT LOW POSITIVE SAMPLES CLOSE TO THE LIMIT OF DETECTION (LOD) OF THE ASSAY. NO INCREASE OF FLUORESCENCE IS DETECTABLE FOR N2 TARGET. RETEST OF THE SAME 2 SAMPLES IN RUN #2843 ON LANES A11 AND A12 OBTAINED COV2 NEGATIVE RESULTS WITHOUT ANY PCR AMPLIFICATION DETECTABLE FOR EITHER N1 OR N2 COV2 TARGETS. SAMPLE A02 IN RUN #2844 HAD A COV2 POSITIVE RESULTS FOR THE N1 TARGET ONLY. IN THE SAME RUN, SAMPLE A11 WAS COV2 POSITIVE FOR BOTH N1 AND N2 TARGETS, WITH A VERY EARLY CT, INDICATING A HIGH LEVEL OF TARGET IN THIS SAMPLE. ALL THE OTHER RESULTS OF THE RUN WERE NEGATIVE. ANALYSIS OF FLUORESCENCE CURVES OF LANE A02 SHOW A WEAK BUT TRUE AMPLIFICATION FOR N1 TARGET. THIS SAMPLE LOOK LIKE A TRUE POSITIVE SAMPLE CLOSE TO THE LIMIT OF DETECTION (LOD) OF THE ASSAY. NO INCREASE OF FLUORESCENCE IS DETECTABLE FOR N2 TARGET. RETEST OF THE SAME SAMPLE IN RUN #2845, ALONG WITH POSITIVE AND NEGATIVE CONTROLS, OBTAINED NEGATIVE RESULTS WITHOUT ANY PCR AMPLIFICATION DETECTABLE FOR EITHER N1 OR N2 TARGETS. BOTH CONTROLS USED IN RUN #2845 GAVE EXPECTED RESULTS. OVERALL, THE MANUAL PCR CURVE ADJUDICATION ANALYSIS INDICATES THAT MOST OF THE N1 ONLY POSITIVE RESULTS ARE CONSISTENT WITH TRUE AMPLIFICATION OF LOW AMOUNT OF TARGET. IN SOME CASES, WEAK FLUORESCENCE INCREASES IN THE CY5 CHANNEL (N2) SUPPORT THE HYPOTHESIS OF DETECTION OF LOW AMOUNT OF TARGET, WHICH COULD COME FROM EITHER THE SAMPLES THEMSELVES OR FROM ENVIRONMENTAL CONTAMINATION DURING SAMPLE OR REAGENT HANDLING. 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 1120321. 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 FALSE POSITIVE RESULTS WERE OBTAINED. REPEAT TESTS WERE PERFORMED USING A CEPHEID TEST 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: " CUSTOMER REPORTING DISCREPANT RESULTS WITH THE BD COV-2 ASSAY. ISSUE OCCURRING WITH SEVERAL DIFFERENT PATIENT SAMPLES. "

    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. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN.

    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 A CEPHEID TEST 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: "CUSTOMER REPORTING DISCREPANT RESULTS WITH THE BD COV-2 ASSAY. ISSUE OCCURRING WITH SEVERAL DIFFERENT PATIENT SAMPLES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1215074 BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM SARS-COV-2 REAGENT KIT QJR BECTON, DICKINSON & CO. (SPARKS) 44500301

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown