BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIT RSV 30 TEST PHYSICIAN VERITOR

    MDR report key: 12197305 · Received July 20, 2021

    Report

    Report Number
    3006948883-2021-00815
    Event Type
    Malfunction
    Date Received
    July 20, 2021
    Date of Event
    June 22, 2021
    Report Date
    December 17, 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

    H6: INVESTIGATION SUMMARY THIS STATEMENT SUMMARIZES THE INVESTIGATION RESULTS REGARDING YOUR COMPLAINT THAT ALLEGES FALSE NEGATIVE WHEN USING KIT RSV 30 TEST PHYSICIAN VERITOR (MATERIAL # 256038), BATCH NUMBERS 0013102, 0142557. BD QUALITY PERFORMS A SYSTEMATIC APPROACH TO INVESTIGATE FALSE NEGATIVE 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 NUMBERS PROVIDED AND NO RELEVANT ISSUE WAS FOUND. THE COMPLAINT WAS UNABLE TO BE CONFIRMED VIA THE RETAIN SAMPLES. PHOTOS WERE PROVIDED. THE PHOTOS CONFIRMED THE REPORTED MULTIPLE LINES COMPLAINT ISSUE. THE BD VERITOR SYSTEM INSTRUMENT (ANALYZER) MUST BE USED FOR INTERPRETATION OF ALL TEST RESULTS. OPERATORS SHOULD NOT ATTEMPT TO VISUALLY INTERPRET ASSAY RESULTS DIRECTLY FROM THE BD VERITOR SYSTEM TEST STRIP (CARTRIDGE). WITH SOME SPECIMENS, UP TO FOUR LINES MAY BE VISIBLE ON THE TEST DEVICE. THE VERITOR ANALYZER WILL APPROPRIATELY INTERPRET THE RESULT. THE ROOT CAUSE WAS TRACED TO FAILURE TO FOLLOW INSTRUCTIONS. A TREND ANALYSIS FOR FALSE NEGATIVE WAS CONDUCTED, NO ADVERSE TREND WAS IDENTIFIED. BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS. THERE WERE NO CORRECTIVE ACTIONS TAKEN AT THIS TIME. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING 4 KIT RSV 30 TEST PHYSICIAN VERITOR FALSE NEGATIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. A REPEAT TEST WAS USED TO CONFIRM THE RESULTS AS FALSE NEGATIVES. 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: "ONE PATIENTS WAS TOOK SAMPLE 2 TIMES. 1 SAMPLE AS TEST IN 2 CARTRIDGE.. THE 1ST SAMPLES WAS TOOK AND TEST WITH: 1 ST CARTRIDGE ( LOT 0142775) AND LABELLED AS 480871 - L1. RESULTS: 3 LINES ON CARTRIDGE - READER GAVE NEG. AFTER THAT 2ND CARTRIDGE ( LOT 0142775) WAS TRIED IT WAS LABELLED AS 480871 - L2. RESULTS: 3 LINES ON CARTRIDGE - READER GAVE POS. "

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0013102. MEDICAL DEVICE EXPIRATION DATE: 2022-10-16. DEVICE MANUFACTURE DATE: 2020-01-13. MEDICAL DEVICE LOT #: 0142557. MEDICAL DEVICE EXPIRATION DATE: 2022-03-08. DEVICE MANUFACTURE DATE: 2020-05-21. 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 4 KIT RSV 30 TEST PHYSICIAN VERITOR FALSE NEGATIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. A REPEAT TEST WAS USED TO CONFIRM THE RESULTS AS FALSE NEGATIVES. 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: "ONE PATIENTS WAS TOOK SAMPLE 2 TIMES. 1 SAMPLE AS TEST IN 2 CARTRIDGE.. THE 1ST SAMPLES WAS TOOK AND TEST WITH: + 1 ST CARTRIDGE ( LOT 0142775) AND LABELLED AS 480871 - L1. RESULTS: 3 LINES ON CARTRIDGE - READER GAVE NEG. + AFTER THAT 2ND CARTRIDGE ( LOT 0142775) WAS TRIED IT WAS LABELLED AS 480871 - L2. RESULTS: 3 LINES ON CARTRIDGE - READER GAVE POS. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1096900 KIT RSV 30 TEST PHYSICIAN VERITOR ANTIGEN, CF (INCLUDING CF CONTROLS), RESPIRATORY SYNCYTIAL VIRUS GQG BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 256038 SEE H.10. 00382902560388

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown