BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIT RSV 30 TEST PHYSICIAN VERITOR

    MDR report key: 12111640 · Received July 2, 2021

    Report

    Report Number
    3006948883-2021-00727
    Event Type
    Malfunction
    Date Received
    July 2, 2021
    Date of Event
    June 1, 2021
    Report Date
    December 9, 2021
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    Product Code
    GQG
    UDI-DI
    00382902560388
    PMA / PMN Number
    K132456
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: THIS STATEMENT IS TO SUMMARIZE THE INVESTIGATION RESULTS REGARDING THE COMPLAINT THAT ALLEGES MULTIPLE LINES ON THE TEST CARTRIDGE RESULTS WHEN USING KIT RSV 30 TEST PHYSICIAN VERITOR (MATERIAL # 256038), BATCH NUMBER 0142557. BD QUALITY PERFORMS A SYSTEMATIC APPROACH TO INVESTIGATE MULTIPLE LINES ON THE TEST CARTRIDGE 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 ISSUE WAS UNABLE TO BE CONFIRMED. THE RETURNED PHOTOGRAPHIC PROVIDED CONFIRMS WITH THE REPORT OF MULTIPLE LINES ON THE TEST CARTRIDGE. NO TREND AGAINST FAILED MULTIPLE LINES ON THE TEST CARTRIDGE WAS IDENTIFIED. THE ROOT CAUSE COULD NOT BE IDENTIFIED. BD QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING KIT RSV 30 TEST PHYSICIAN VERITOR FALSE POSITIVE REUSLTS WERE OBTAINED BY THE LABORATORY PERSONNEL. AN ASAN TEST WAS USED TO CONFIRM THE RESULTS AS FALSE POSITIVES. 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: " AFTER PROCESSING SAMPLE WAS ADDED IN TO THE BD VERITOR RSV CARTRIDGE. AFTER INCUBATION TIME, 3 LINES WERE APPEARED ON THE CARTRIDGE, AND VERITOR PLUS ANALYSIS GAVE POSITIVE RESULT. "

    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 KIT RSV 30 TEST PHYSICIAN VERITOR FALSE POSITIVE REUSLTS WERE OBTAINED BY THE LABORATORY PERSONNEL. AN ASAN TEST WAS USED TO CONFIRM THE RESULTS AS FALSE POSITIVES. 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: " AFTER PROCESSING SAMPLE WAS ADDED IN TO THE BD VERITOR RSV CARTRIDGE. AFTER INCUBATION TIME, 3 LINES WERE APPEARED ON THE CARTRIDGE, AND VERITOR PLUS ANALYSIS GAVE POSITIVE RESULT. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1002358 KIT RSV 30 TEST PHYSICIAN VERITOR ANTIGEN, CF (INCLUDING CF CONTROLS), RESPIRATORY SYNCYTIAL VIRUS GQG BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 256038 0142557 00382902560388

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown