BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIT FLU VERITOR SYSTEM 30 TEST JAPAN

    MDR report key: 11528993 · Received March 19, 2021

    Report

    Report Number
    3006948883-2021-00312
    Event Type
    Malfunction
    Date Received
    March 19, 2021
    Date of Event
    February 18, 2021
    Report Date
    July 2, 2021
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    Product Code
    PSZ
    PMA / PMN Number
    K112277
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY BD POINT OF CARE QUALITY INITIATED INVESTIGATION ON THE CUSTOMER REPORT REGARDING ALLEGED FALSE POSITIVE WHEN USING THE KIT FLU VERITOR SYSTEM 30 TEST JAPAN (REF# (B)(4).). BD TAKES A SYSTEMATIC APPROACH TO INVESTIGATING FALSE POSITIVE COMPLAINTS THAT ARE RECEIVED. THIS APPROACH INVOLVES REVIEW OF MANUFACTURING BATCH HISTORY RECORDS, TESTING OF RETENTION SAMPLES, AND TESTING OF CUSTOMER RETURNED SAMPLES IF APPLICABLE. THERE WAS NO LOT NUMBER DOCUMENTED IN THE SUBMISSION OF THIS COMPLAINT; THEREFORE NO INTERNAL INVESTIGATIONS CAN BE PERFORMED AND THE ISSUE CANNOT BE CONFIRMED. NO RETURNS WERE RECEIVED TO INVESTIGATE. THE INVESTIGATION DID NOT FIND A ROOT CAUSE FOR THE FALSE POSITIVE RESULTS REPORTED. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. BD POINT OF CARE WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS ASSOCIATED WITH FALSE POSITIVE WHEN USING THE KIT FLU VERITOR SYSTEM 30 TEST JAPAN (REF# (B)(4).). THERE WAS NO CORRECTIVE ACTION TAKEN AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING KIT FLU VERITOR SYSTEM 30 TEST JAPAN 5 FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT.

    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. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN DEVICE MANUFACTURE DATE: UNKNOWN THERE IS NO 510(K) FOR THIS DEVICE AS IT IS MANUFACTURED OUTSIDE THE US AND NOT SOLD IN THE US BUT IS CONSIDERED TO BE SUBSTANTIALLY SIMILAR TO THE LEGALLY U.S. MARKETED DEVICE KIT FLU A+B 30 TEST PHYSICIAN VERITOR CATALOG NUMBER 256045 WHICH HAS 510K #: K112277

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING KIT FLU VERITOR SYSTEM 30 TEST JAPAN 5 FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425211 KIT FLU VERITOR SYSTEM 30 TEST JAPAN DEVICES DETECTING INFLUENZA A, B, AND C VIRUS ANTIGENS PSZ BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1