BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF RSV - LABORATORY KIT

    MDR report key: 14077321 · Received April 11, 2022

    Report

    Report Number
    3006948883-2022-00110
    Event Type
    Malfunction
    Date Received
    April 11, 2022
    Date of Event
    March 15, 2022
    Report Date
    April 18, 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

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY THIS STATEMENT IS TO SUMMARIZE THE INVESTIGATION RESULTS REGARDING YOUR COMPLAINT THAT ALLEGES FALSE POSITIVE WHEN USING KIT RSV 30 TEST HOSPITAL VERITOR (MATERIAL # 256042), BATCH NUMBER 0128221. 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. A PHOTOGRAPH WAS RETURNED AND SHOWED KIT RSV 30 TEST HOSPITAL VERITOR'S TEST RESULTS AND UNABLE TO CONFIRM OF FALSE POSITIVE. THE REPORTED ISSUE WAS UNABLE TO BE CONFIRMED. THE ROOT CAUSE COULD NOT BE IDENTIFIED. NO TREND AGAINST FALSE POSITIVE WAS IDENTIFIED. CURRENTLY NO ADVERSE TREND FOR FALSE POSITIVE WAS IDENTIFIED. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE TESTING WITH BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF RSV - LABORATORY KIT FALSE POSITIVE RESULTS WERE OBTAINED. TESTING WAS REPEATED AND RESULT WAS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: WE OBSERVE MANY FALSE POSITIVE RESULTS WITH LOT NUMBER 128221 OF BD'S RSV ANTIGEN TEST. WE OBTAIN A LINE AT THE CONTROL AND TEST LINE BUT WITH A WIPE THROUGH. IS READ AS POSITIVE BY READER BUT LOOKS DIFFERENT THAN NORMAL. WHEN WE REPEAT SAMPLE THIS ATYPICAL BINDING IS GONE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE TESTING WITH BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF RSV - LABORATORY KIT FALSE POSITIVE RESULTS WERE OBTAINED. TESTING WAS REPEATED AND RESULT WAS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM DUTCH TO ENGLISH: WE OBSERVE MANY FALSE POSITIVE RESULTS WITH LOT NUMBER 128221 OF BD'S RSV ANTIGEN TEST. WE OBTAIN A LINE AT THE CONTROL AND TEST LINE BUT WITH A WIPE THROUGH. IS READ AS POSITIVE BY READER BUT LOOKS DIFFERENT THAN NORMAL. WHEN WE REPEAT SAMPLE THIS ATYPICAL BINDING IS GONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133702 BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF RSV - LABORATORY KIT ANTIGEN, CF (INCLUDING CF CONTROLS), RESPIRATORY SYNCYTIAL VIRUS GQG BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 256042 0128221 00382902560425

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown