BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VERITOR SYSTEM FOR RAPID DETECTION OF RSV

    MDR report key: 12760763 · Received November 7, 2021

    Report

    Report Number
    3006948883-2021-00994
    Event Type
    Malfunction
    Date Received
    November 7, 2021
    Date of Event
    October 9, 2021
    Report Date
    January 20, 2022
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    Product Code
    GQG
    UDI-DI
    00382902560425
    PMA / PMN Number
    K133140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY THIS STATEMENT IS TO SUMMARIZE THE INVESTIGATION RESULTS REGARDING YOUR COMPLAINT THAT ALLEGES FALSE POSITIVE RESULTS WHEN USING KIT RSV 30 TEST HOSPITAL VERITOR (MATERIAL # 256042), BATCH NUMBER 9301451. BD QUALITY PERFORMS A SYSTEMATIC APPROACH TO INVESTIGATE FALSE POSITIVE COMPLAINTS. THIS APPROACH INVOLVES REVIEW OF MANUFACTURING BATCH HISTORY RECORDS, TESTING OF RETENTION SAMPLES, AND TESTING OF CUSTOMER RETURNED SAMPLES, IF APPLICABLE. AN INVESTIGATION AND TESTING WERE PERFORMED ON THE BATCH NUMBER PROVIDED. THE REPORTED WAS UNABLE TO BE CONFIRMED. THE ROOT CAUSE COULD NOT BE IDENTIFIED. BD QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    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 · 0

    IT WAS REPORTED THAT A FALSE POSITIVE RESULT FOR FLU A AND RSV WAS PRODUCED BY THE BD VERITOR SYSTEM FOR RAPID DETECTION OF RSV. CONFIRMATORY TESTING WAS NOT PERFORMED, AND CLINICIANS WERE NOT NOTIFIED OF THE ERRONEOUS RESULTS. THERE WAS ALSO NO REPORT OF ADVERSE PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FALSE POSITIVE RESULT NOT CONFIRMED BY REAL TIME PCR FALSE POSITIVE RESULT FOR A CLINICAL SAMPLE, NASOPHARYNGEAL SWAB IN NACL 0,9% FROM A PATIENT... NOT CONFIRMED BY REAL TIME PCR. VISUAL INSPECTION OF THE VERITOR DEVICE SHOWED A VERY LIGHT LINE WHICH WAS INTERPRETED BY THE VERITOR PLUS ANALYSE AS POSITIVE. THE SAME SAMPLE WAS TESTED FALSE POSITIVE FOR RSV, ALSO NOT CONFIRMED BY REAL TIME PCR. PATIENT WAS SARS-COV 2 NEGATIVE." "NO INCORRECT RESULTS WERE REPORTED. " SAME SAMPLE (FROM THE SAME PATIENT) WAS FALSE POSITIVE FOR FLUA AND RSV. ONLY WHEN A SAMPLE IS POSITIVE FOR BOTH FLUA & RSV , WITH A WEAK LINE, A PCR TEST IS PERFORMED FOR CONFIRMATION. ALSO FOR THIS CASE , THE CLINICAL SYMPTONS WERE NOT CORRELATING WITH A POSITIVE RESULT FOR FLUA AND RSV.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A FALSE POSITIVE RESULT FOR FLU A AND RSV WAS PRODUCED BY THE BD VERITOR SYSTEM FOR RAPID DETECTION OF RSV. CONFIRMATORY TESTING WAS NOT PERFORMED, AND CLINICIANS WERE NOT NOTIFIED OF THE ERRONEOUS RESULTS. THERE WAS ALSO NO REPORT OF ADVERSE PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FALSE POSITIVE RESULT NOT CONFIRMED BY REAL TIME PCR FALSE POSITIVE RESULT FOR A CLINICAL SAMPLE, NASOPHARYNGEAL SWAB IN NACL 0,9% FROM A PATIENT... NOT CONFIRMED BY REAL TIME PCR. VISUAL INSPECTION OF THE VERITOR DEVICE SHOWED A VERY LIGHT LINE WHICH WAS INTERPRETED BY THE VERITOR PLUS ANALYSE AS POSITIVE. THE SAME SAMPLE WAS TESTED FALSE POSITIVE FOR RSV, ALSO NOT CONFIRMED BY REAL TIME PCR. PATIENT WAS SARS-COV 2 NEGATIVE" "NO INCORRECT RESULTS WERE REPORTED" " SAME SAMPLE (FROM THE SAME PATIENT) WAS FALSE POSITIVE FOR FLUA AND RSV ONLY WHEN A SAMPLE IS POSITIVE FOR BOTH FLUA & RSV, WITH A WEAK LINE, A PCR TEST IS PERFORMED FOR CONFIRMATION. ALSO FOR THIS CASE , THE CLINICAL SYMPTOMS WERE NOT CORRELATING WITH A POSITIVE RESULT FOR FLUA AND RSV"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1662292 BD VERITOR SYSTEM FOR RAPID DETECTION OF RSV RESPIRATORY SYNCYTIAL VIRUS ANTIGEN, CF GQG BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 256042 9301451 00382902560425

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown