BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SARS-COV-2 REAGENTS FOR BD MAX SYSTEM

    MDR report key: 11363303 · Received February 22, 2021

    Report

    Report Number
    1119779-2021-00346
    Event Type
    Malfunction
    Date Received
    February 22, 2021
    Date of Event
    January 26, 2021
    Report Date
    April 15, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    QJR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS WHEN USING THE BD MAX SARS-COV-2 REAGENTS (REF# 44500301) LOT 0240505 WAS PERFORMED BY THE REVIEW OF THE MANUFACTURING RECORDS, ANALYSIS OF THE CUSTOMER¿S DATA AND VERIFICATION OF COMPLAINTS HISTORY. REVIEW OF THE MANUFACTURING RECORDS OF THE BD MAX SARS-COV-2 REAGENTS INDICATED THAT THE LOT 0240505 WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER COMPLAINED OF POSITIVE RESULTS ON SPECIMENS TESTED WITH THE BD SARS-COV-2 REAGENTS FOR BD MAX SYSTEM KIT LOT 0240505, WHICH WERE NEGATIVE WHEN REPEATED WITH A NEW KIT LOT (0259529). CUSTOMER REPORTED ALSO A HIGH RATE OF POSITIVE RESULTS (RATE OF 70 - 80%) WITH BD SARS-COV-2 REAGENTS FOR BD MAX SYSTEM KIT LOT 0240505. THEY MENTIONED THAT THE BD SARS-COV-2 REAGENTS FOR BD MAX SYSTEM KIT LOT 0240505 WAS RECEIVED AT AN UNUSUALLY HIGH TEMPERATURE OF 32.3°C AND SUSPECTED THIS TO BE LINKED TO THE FALSE POSITIVE RESULTS THEY OBTAINED WITH THIS LOT. ALTHOUGH, NO EVIDENCE LINKING TEMPERATURE EXCURSIONS WITH FALSE POSITIVE RESULTS HAS BEEN SHOWN, IT IS DIFFICULT TO ASSESS THE IMPACT OF THIS SPECIFIC EXCURSION ON PRODUCT PERFORMANCE. THE PRODUCT IS REQUIRED TO BE STORED BETWEEN 2 TO 25°C. CUSTOMER PROVIDED TWO RUNS FILES: RUN #749 TESTED WITH KIT LOT 0240505, CONTAINING PATIENT SAMPLES, AND RUN #751, TESTED WITH KIT LOT 0259529, CONTAINING THE SAME PATIENT SAMPLES (REPEAT TEST). CUSTOMER MENTIONED SIX DISCREPANT SAMPLES HOWEVER ONE OF THEM (SAMPLE 606) IS NOT DISCREPANT WHILE SAMPLE 640, ALTHOUGH NOT MENTIONED IN THE COMPLAINT DETAILS, WAS FOUND DISCREPANT. MANUAL PCR CURVE ADJUDICATION WAS CONDUCTED ACROSS ALL SAMPLES WITH DISCREPANT RESULTS (SAMPLE ID: 600, 626, 633, 640, 642 AND 643). 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. ANALYSIS OF PCR CURVES OF ALL POTENTIAL DISCREPANT SAMPLE SHOW TRUE AMPLIFICATIONS FOR N1 AND/OR N2 TARGET WITHOUT ANOMALY, INDICATIVE OF TRUE POSITIVE RESULTS. OVERALL, THESE SAMPLES APPEAR TO BE TRUE LOW POSITIVES. IT MUST BE NOTED THAT LOW POSITIVE SAMPLES, WITH VIRAL TITERS CLOSE TO THE LIMIT OF DETECTION, CAN CHANGE STATUS UPON REPEAT. CUSTOMER PROVIDED THREE OTHER RUNS (759, 762 AND 763) BUT NO DISTINCT DISCREPANT SAMPLE WAS SPECIFIED. RUN 759 OBTAINED 10/12 POSITIVE RESULTS, USING A KIT LOT NOT DESCRIBED IN THE COMPLAINT (LOT# 0259529). THE FACT THAT MANY POSITIVE RESULTS WERE OBTAINED WITH A DIFFERENT LOT IN THE SAME PERIOD SUGGESTS THAT THE ISSUE IS NOT LIMITED TO ONE SPECIFIC LOT. RUN 762 (PERFORMED WITH KIT LOT 0240505) CONTAINED SOME WATER SAMPLES, AS WELL AS ENVIRONMENTAL MONITORING SAMPLES, AND POSITIVE RESULTS WERE OBTAINED. THE LAST RUN SENT (763) WAS PERFORMED WITH THE KIT LOT #0240505 AND ACCORDING TO THE CUSTOMER, GAVE EXPECTED RESULTS. CONSIDERING ALL THESE RESULTS, THE FACT THAT ENVIRONMENTAL MONITORING SAMPLES YIELDED POSITIVE RESULTS SUGGESTS CONTAMINATION DURING SAMPLE PREPARATION AND/OR MATERIAL HANDLING THAT COULD HAVE CONTRIBUTED TO SOME OF THE POSITIVE RESULTS IN ALL THE RUNS ANALYZED. LOW POSITIVE SAMPLES CAN ALSO OCCUR DUE TO VIRAL TITERS IN THE SPECIMEN BEING AT OR NEAR THE LIMIT OF DETECTION OF THE ASSAY. NO PRODUCT ISSUE IS SUSPECTED. BD WAS UNABLE TO CONFIRM THE EXACT CAUSE OF THE CUSTOMER¿S POSITIVE RESULTS. HOWEVER, NO PRODUCT ISSUE IS SUSPECTED. THERE IS NO INDICATION OF AN INCREASE IN COMPLAINTS FOR DISCREPANT RESULTS FOR BD MAX SARS-COV-2 REAGENTS LOT # 0240505. THE ROOT CAUSE WAS NOT IDENTIFIED. 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. REPEAT TEST PERFORMED AND RESULT WAS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT. (B)(4).

    Additional Manufacturer Narrative · 1

    EUA# (B)(4). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE TESTING FOR SARS-COV-2 A FALSE POSITIVE RESULT WAS OBTAINED. REPEAT TEST PERFORMED AND RESULT WAS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT. EUA# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254850 BD SARS-COV-2 REAGENTS FOR BD MAX SYSTEM SARS-COV-2 REAGENT KIT QJR BECTON, DICKINSON & CO. (SPARKS) 0240505

    Patients

    Seq Age Sex Outcome Treatment
    1