BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAX¿ INSTRUMENT, REMANUFACTURED

    MDR report key: 11757663 · Received April 30, 2021

    Report

    Report Number
    1119779-2021-00752
    Event Type
    Malfunction
    Date Received
    April 30, 2021
    Date of Event
    April 7, 2021
    Report Date
    January 31, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    OOI
    UDI-DI
    00382904419165
    PMA / PMN Number
    K111860
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A "FALSE POSITIVE" RESULT COMPLAINT WAS REPORTED AGAINST THE BD MAX INSTRUMENT, CATALOG NUMBER 441916, SERIAL NUMBER (B)(6). THE CUSTOMER REPORTED THAT THEY RECEIVED NUMEROUS FALSE POSITIVE RESULTS ON TWO COVID-19 ASSAY RUN. FIELD SERVICE WAS NOT DISPATCHED. REVIEW OF CUSTOMER PCR CURVES SHOWS THAT ONE SAMPLE IN EACH RUNS IS A GENE REACTION WHILE THE REMAINING WERE DUE TO NON-SPECIFIC REACTION. THE NEGATIVE IS DUE TO LOW VIRAL LOAD. CUSTOMER WAS ALSO RECOMMENDED TO PERFORM CLEANING INSIDE THE INSTRUMENT TO RULE OUT POTENTIAL CONTAMINATION. NO BD ACTIONS WERE TAKEN. NO PARTS WERE REPLACED NOR RETURNED TO BD FOR INVESTIGATION. ROOT CAUSE CANNOT BE DETERMINED WITH INFORMATION PROVIDED. COMPLAINT IS UNCONFIRMED AS AN INSTRUMENT ISSUE AS THE REVIEW OF THE PCR CURVES SHOWS TRUE REACTIONS. INVESTIGATION CONSISTED OF A REVIEW OF THE INSTRUMENT INSTALLATION, SERVICE HISTORY, AND RELATED COMPLAINT DATA. NO NEW RISKS, TRENDS, OR HAZARDS WERE IDENTIFIED. BD WILL CONTINUALLY MONITOR FOR TREND.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE TESTING FOR SARS-COV-2 WITH BD MAX¿ INSTRUMENT, REMANUFACTURED FALSE POSITIVE RESULTS WERE OBTAINED. SAMPLES WERE RETESTED AND THE RESULT WAS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT. (B)(4) THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: BD SARS-COV-2 FALSE POSITIVES RUN90: DATA MEASURED BY ME LAST SUNDAY 2 OUT OF 22 SAMPLES WERE (+). THE TWO WHO BECAME (+) ARE PARENTS AND CHILDREN, WHICH MAY BE A COINCIDENCE. AFTER THIS, 9 SAMPLES WERE MEASURED INCLUDING THE RETESTED DATA, BUT ALL WERE (-). THE POSITIVE NUMBERS ARE A6 AND A11. (2) RUN96: 4 OUT OF 7 DATA MEASURED BY ANOTHER ENGINEER ON THE 6TH TODAY WERE (-), AND AFTER THAT, THEY WERE RETESTED, BUT ALL WERE (-). THE POSITIVE NUMBERS ARE B1, B2, B3 AND B5. APART FROM THIS, 7 SAMPLES WERE MEASURED YESTERDAY AND 5TH, BUT ALL OF THEM WERE (-). ALL SPECIMENS WILL BE IN THE NASOPHARYNX. THERE WAS NO MEASUREMENT REGULARITY.

    Additional Manufacturer Narrative · 1

    EUA# (B)(4). MEDICAL DEVICE EXPIRATION DATE: NA. THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL 510K IS AS FOLLOWS: PMA / 510(K)#: K130470. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE TESTING FOR SARS-COV-2 WITH BD MAX" INSTRUMENT, REMANUFACTURED FALSE POSITIVE RESULTS WERE OBTAINED. SAMPLES WERE RETESTED AND THE RESULT WAS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT. EUA# (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: BD SARS-COV-2 FALSE POSITIVES. RUN90: DATA MEASURED BY ME LAST SUNDAY 2 OUT OF 22 SAMPLES WERE (+). THE TWO WHO BECAME (+) ARE PARENTS AND CHILDREN, WHICH MAY BE A COINCIDENCE. AFTER THIS, 9 SAMPLES WERE MEASURED INCLUDING THE RETESTED DATA, BUT ALL WERE (-). THE POSITIVE NUMBERS ARE A6 AND A11. (2) RUN96: 4 OUT OF 7 DATA MEASURED BY ANOTHER ENGINEER ON THE (B)(6) TODAY WERE (-), AND AFTER THAT, THEY WERE RETESTED, BUT ALL WERE (-). THE POSITIVE NUMBERS ARE B1, B2, B3 AND B5. APART FROM THIS, 7 SAMPLES WERE MEASURED YESTERDAY AND (B)(6), BUT ALL OF THEM WERE (-). ALL SPECIMENS WILL BE IN THE NASOPHARYNX. THERE WAS NO MEASUREMENT REGULARITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649400 BD MAX¿ INSTRUMENT, REMANUFACTURED INSTRUMENTATION FOR CLINICAL MULTIPLEX TEST SYSTEMS OOI BECTON, DICKINSON & CO. (SPARKS) 441916 NA 00382904419165

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown