BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD VERITOR SYSTEM FOR RSV ASSAYS

    MDR report key: 16845427 · Received May 1, 2023

    Report

    Report Number
    3014704491-2023-00156
    Event Type
    Injury
    Date Received
    May 1, 2023
    Date of Event
    March 24, 2023
    Report Date
    May 31, 2023
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    Product Code
    GQG
    UDI-DI
    00382902560425
    PMA / PMN Number
    K133140
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: THIS STATEMENT IS TO SUMMARIZE THE INVESTIGATION RESULTS REGARDING A COMPLAINT THAT ALLEGES FALSE POSITIVE AND FALSE NEGATIVE RESULT WHEN USING KIT RSV 30 TEST HOSPITAL VERITOR (MATERIAL # 256042, BATCH NUMBER 1123929. BD QUALITY PERFORMS A SYSTEMATIC APPROACH TO INVESTIGATE ALL COMPLAINTS. THIS APPROACH INVOLVES REVIEW OF MANUFACTURING BATCH HISTORY RECORDS, TESTING OF RETENTION SAMPLES, AND TESTING OF CUSTOMER RETURNED SAMPLES, IF APPLICABLE. BASED ON THE PROVIDED INFORMATION, IT WAS UNDERSTOOD THAT THE CUSTOMER RECEIVED ONE FALSE POSITIVE AND ONE FALSE NEGATIVE RESULT WITH VERITOR. THE RESULTS WERE COMPARED WITH A SECONDARY ANALYSIS BY ANOTHER REFERENCE LABORATORY THROUGH MOLECULAR ANALYSIS (PCR). UPON FOLLOW-UP WITH THE CUSTOMER IN RELATION TO THE PROCEDURE USED, IT WAS IDENTIFIED THAT A POSSIBLE FACTOR THAT COULD AFFECT THE RESULT WAS THAT THE CUSTOMER USED REPACKAGED SALINE SOLUTION AND MAXIMUM TIME OF REFERRAL OF SAMPLES TO LSP OF 72 HOURS, SPECIALIST REPORTED THAT THERE WAS NO KNOWN STABILITY OF THE PCR TEST IN SALINE SOLUTION. IT IS RECOMMENDED NOT TO USE REPACKAGE SALINE SOLUTION. A BATCH HISTORY RECORD (BHR) REVIEW AND RETENTION TESTING WERE PERFORMED ON BATCH NUMBER PROVIDED. RESULTS WERE ACCEPTABLE AND NO RELEVANT ISSUES WERE FOUND. NO PHYSICAL SAMPLES WERE RETURNED; THEREFORE, RETURN SAMPLE ANALYSIS COULD NOT BE PERFORMED. CUSTOMER SENT IMAGES OF VERITOR TEST RESULTS AND PCR ANALYSIS REPORT WHICH CONFIRMED THE REPORTED ISSUE. THIS COMPLAINT WAS CONFIRMED BASED ON THE DATA PROVIDED BY THE CUSTOMER. CURRENTLY, THERE ARE NO ADVERSE TRENDS IDENTIFIED FOR THE REPORTED ISSUE. H3 OTHER TEXT : SEE H.10.

    Additional Manufacturer Narrative · 0

    E.6 INITIAL REPORTER EMAIL: (B)(6). H.3. 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 · 0

    REPORT 2 OF 2. IT WAS REPORTED THAT WHILE USING THE BD VERITOR SYSTEM FOR RSV ASSAYS THAT THERE WAS A FALSE NEGATIVE WAS OBTAINED, CONFIRMATION WAS DONE BY PCR. PATIENT HOSPITAL STAY WAS EXTENDED, NO TREATMENT INFORMATION WAS PROVIDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RSV (RESPIRATORY SYNCYTIAL VIRUS-RSV) FALSE NEGATIVE SECONDARY ANALYSIS BY ANOTHER REFERENCE LABORATORY THROUGH MOLECULAR ANALYSIS (PCR).

    Description of Event or Problem · 0

    REPORT 2 OF 2 IT WAS REPORTED THAT WHILE USING THE BD VERITOR SYSTEM FOR RSV ASSAYS THAT THERE WAS A FALSE NEGATIVE WAS OBTAINED, CONFIRMATION WAS DONE BY PCR. PATIENT HOSPITAL STAY WAS EXTENDED, NO TREATMENT INFORMATION WAS PROVIDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RSV (RESPIRATORY SYNCYTIAL VIRUS-RSV) FALSE NEGATIVE SECONDARY ANALYSIS BY ANOTHER REFERENCE LABORATORY THROUGH MOLECULAR ANALYSIS (PCR).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702283 BD VERITOR SYSTEM FOR RSV ASSAYS NA GQG BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 256042 1123929 00382902560425

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Male Hospitalization