BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VERITOR PLUS ANALYZER

    MDR report key: 12366430 · Received August 25, 2021

    Report

    Report Number
    1119779-2021-01428
    Event Type
    Malfunction
    Date Received
    August 25, 2021
    Date of Event
    July 26, 2021
    Report Date
    April 1, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JJQ
    UDI-DI
    00382902560661
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTIONS: B.5. EVENT DESCRIPTION: IT WAS REPORTED THAT WHILE USING BD VERITOR PLUS ANALYZER ¿A MISASSOCIATION WAS OBSERVED BY THE LABORATORY PERSONNEL. A REPEAT TEST WAS USED TO CONFIRM THE MISASSOCIATION. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " IT WAS REPORTED THAT HE ANALYZER REGISTERED A NEGATIVE BUT SYNAPSYS REGISTERED A POSITIVE. " D.1. DEVICE BRAND NAME: BD VERITOR PLUS ANALYZER. D.2. DEVICE TYPE: JJQ; COMMON DEVICE NAME: ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP. D.4. DEVICE CATALOG #: 256066; UDI #: (B)(4); SERIAL #: (B)(6). H.4. DEVICE CREATION DATE: 2021-02-08.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: THE COMPLAINT WAS CREATED FOR SYNAPSYS COMMUNICATION ISSUES ON THE BD VERITOR PLUS ANALYZER (P/N 256066, S/N (B)(6). THE CUSTOMER REPORTS ISSUE WHERE MISMATCH IN RESULT REGISTERED WITH SYNAPSYS. THE DEVICE HISTORY RECORD FOR BD VERITOR PLUS ANALYZER, SN (B)(6), WAS EXAMINED AND SHOWED NO DISCREPANCIES RELATE TO THIS ISSUE THAT CAN BE CORRELATED TO THIS COMPLAINT. THE READER PASSED ALL TESTS INCLUDING THE FINAL ASSEMBLY PROCESS, OQA, SOURCE INSPECTION, FUNCTIONALITY, AND FINAL PACKING TEST AND MANUAL INSPECTION. THE VERITOR PLUS ANALYZER, SN (B)(6), WAS NOT RETURNED FOR INVESTIGATION. BD VERITOR PLUS ANALYZER WAS NOT RETURNED FOR INVESTIGATION AND THE PICTURES PROVIDED BY THE CUSTOMER ARE NOT ENOUGH TO CONFIRM THE ISSUE. THEREFORE THE ROOT CAUSE CANNOT BE DETERMINED AS CSV FILES WERE NOT AVAILABLE. BASED ON THESE EVIDENCES THE COMPLAINT IS UNCONFIRMED. BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS RELATED TO THE VERITOR SYSTEM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD VERITOR PLUS ANALYZER A MISASSOCIATION WAS OBSERVED BY THE LABORATORY PERSONNEL. A REPEAT TEST WAS USED TO CONFIRM THE MISASSOCIATION. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " IT WAS REPORTED THAT HE ANALYZER REGISTERED A NEGATIVE BUT SYNAPSYS REGISTERED A POSITIVE. "

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD VERITOR PLUS ANALYZER ¿A MISASSOCIATION WAS OBSERVED BY THE LABORATORY PERSONNEL. A REPEAT TEST WAS USED TO CONFIRM THE MISASSOCIATION. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " IT WAS REPORTED THAT HE ANALYZER REGISTERED A NEGATIVE BUT SYNAPSYS REGISTERED A POSITIVE. "

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING BD SYNAPSYS¿ A MISASSOCIATION WAS OBSERVED BY THE LABORATORY PERSONNEL. A REPEAT TEST WAS USED TO CONFIRM THE MISASSOCIATION. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT HE ANALYZER REGISTERED A NEGATIVE BUT SYNAPSYS REGISTERED A POSITIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1265993 BD VERITOR PLUS ANALYZER ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP. JJQ BECTON, DICKINSON & CO. (SPARKS) 256066 00382902560661
    1266006 BD VERITOR PLUS ANALYZER ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP. JJQ BECTON, DICKINSON & CO. (SPARKS) 256066 00382902560661

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown