BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SARS-COV-2 REAGENTS FOR BD MAX SYSTEM

    MDR report key: 10374923 · Received August 6, 2020

    Report

    Report Number
    1119779-2020-00265
    Event Type
    Malfunction
    Date Received
    August 6, 2020
    Date of Event
    July 9, 2020
    Report Date
    October 7, 2020
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    QJR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.4. MEDICAL DEVICE LOT #: 0099417. D.4. MEDICAL DEVICE EXPIRATION DATE: 2020-10-09. H.4. DEVICE MANUFACTURE DATE: 2020-04-08. INVESTIGATION SUMMARY: THE COMPLAINT INVESTIGATION FOR FALSE POSITIVE AND INDETERMINATE (IND) RESULTS WHEN USING THE KIT BD MAX SARS-COV-2 REAGENTS (REF (B)(64) ASSAY KIT LOT 0099417 WAS PERFORMED BY THE REVIEW OF THE MANUFACTURING RECORDS, REVIEW OF THE CUSTOMER DATA AND VERIFICATION OF COMPLAINTS HISTORY. REVIEW OF THE MANUFACTURING RECORDS OF BD MAX SARS COV-2 INDICATED THAT THE QC RESULTS WERE COMPLIANT. REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED ON THE BD MAX¿ EXK¿ TNA-3 KIT LOT 0091432 PRODUCT USED ALONG THE BD SARS-COV-2 REAGENTS AND INDICATED THAT THE RESULTS WERE ALL CONFORMING. THE CUSTOMER REPORTED ISSUE WITH TWO PATIENTS RESULTS: SAMPLE 34A (RUN#735 A10) & 33A (RUN #735 A11). CUSTOMER PROVIDED DATABASE FOR ANALYSIS. THE FIRST SAMPLE, #34A (RUN#735 A10), INITIALLY GAVE AN IND RESULT CAUSED BY A READER WARNING SATURATION. BD HAS RECEIVED MULTIPLE COMPLAINTS FOR A SIMILAR ISSUE WITH THE BD SARS COV-2 ASSAY, ALL FOR READER SATURATION WARNING ERROR CODES. ANALYSIS OF THE VARIOUS DATABASES RECEIVED FROM CUSTOMERS FOR OTHER COMPLAINTS REVEALED EVIDENCE OF SIMILAR PATTERNS. THE INITIAL FLUORESCENCE IN PCR CHANNEL ARE HIGHER WITH THE BD SARS-COV-2 REAGENTS THAN ALL OTHER ASSAYS. CONSEQUENTLY, SOME SAMPLES REACH THE MAXIMUM POSSIBLE FLUORESCENCE VALUE AT THE BEGINNING OF THE PCR RUN, RESULTING IN A READER SATURATION WARNING ERROR CODE. IN ALL CASES, THE PRODUCT DESIGN, WITH CONTRIBUTION OF THE INSTRUMENT, ARE SUSPECTED TO BE IN CAUSE. THE SECOND SAMPLE, #33A, INITIALLY GAVE A POSITIVE RESULT FOR BOTH N1 AND N2 TARGETS, BUT REPEATED NEGATIVE TWICE. CURVES ANALYSIS, IN RUN 735, POSITION A11, SHOWS IRREGULAR CURVE WITH GLITCHES AT THE SAME CT VALUE IN BOTH TARGET CHANNELS. THE GLITCHES SEEM TO CAUSE AN INTERRUPTION IN BACKGROUND CORRECTION, GENERATING A STEADY INCREASE OF FLUORESCENCE RESULTING IN A POSITIVE RESULT IN BOTH CHANNELS. THE SAMPLE 33A WAS REPEATED TWO OTHER TIMES, IN RUN 737 POSITIONS A10 & A11 AND DID NOT SHOW AMPLIFICATION, CONFIRMING THE NEGATIVE STATUS OF THIS SAMPLE. MOREOVER, THE GLITCH IN CURVE OF SAMPLE 33A COULD HAVE BEEN CAUSED BY BUBBLES IN THE CARTRIDGE, POTENTIALLY LINKED TO AN UNKNOWN INSTRUMENT ISSUE OR TO 175L TIPS INCLUDED IN THE BD MAX¿ EXK¿ TNA-3 KIT LOT 0091432, USED BY THE CUSTOMER, ARE A KNOWN SOURCE OF BUBBLES IN PCR CARTRIDGE WELLS (EMPTY OR PARTIALLY FILLED WELLS). THERE IS NO TREND FOR FALSE POSITIVE AND INDETERMINATE RESULTS ON BD SARS-COV-2 REAGENTS FOR BD MAXTM SYSTEM LOT 0099417. THE ROOT CAUSE WAS NOT IDENTIFIED. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. A CORRECTIVE AND PREVENTIVE ACTION (CAPA) 1632720 WAS INITIATED TO INVESTIGATE THE ROOT CAUSE OF THE HIGH BACKGROUND FLUORESCENCE VALUES AND SOME MITIGATION ACTIONS ARE ALREADY IN PROCESS. IN ADDITION TO THAT A CORRECTIVE AND PREVENTIVE ACTION 1177233 IS ALREADY INITIATED TO INVESTIGATE THE 175L TIPS CONTRIBUTION. (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM A FALSE POSITIVE RESULT WAS OBTAINED BY THE LABORATORY PERSONNEL. UPON REPEAT THE SAMPLE WAS NEGATIVE. NO ERRONEOUS RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. (B)(4).

    Additional Manufacturer Narrative · 1

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM A FALSE POSITIVE RESULT WAS OBTAINED BY THE LABORATORY PERSONNEL. UPON REPEAT THE SAMPLE WAS NEGATIVE. NO ERRONEOUS RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. EUA #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841471 BD SARS-COV-2 REAGENTS FOR BD MAX SYSTEM SARS-COV-2 REAGENT KIT QJR BECTON, DICKINSON & CO. 0099417

    Patients

    Seq Age Sex Outcome Treatment
    1 Other