BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIT FLU VERITOR SYSTEM 30 TEST JAPAN

    MDR report key: 13641122 · Received March 1, 2022

    Report

    Report Number
    3006948883-2022-00046
    Event Type
    Malfunction
    Date Received
    March 1, 2022
    Date of Event
    February 2, 2022
    Report Date
    March 4, 2022
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. 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 NUMBER K112277.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: THIS MEMO IS TO SUMMARIZE THE INVESTIGATION RESULTS REGARDING THE COMPLAINT THAT ALLEGES FALSE POSITIVE WHEN USING KIT FLU VERITOR SYSTEM 30 TEST JAPAN (MATERIAL # 256052), BATCH NUMBER UNKNOWN. 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 COULD NOT BE PERFORMED AS NO BATCH NUMBER WAS PROVIDED. A PHOTOGRAPH WAS RETURNED AND SHOWED TWO KIT FLU VERITOR SYSTEM 30 TEST JAPAN TEST DEVICE WITH RESULTS AND UNABLE TO CONFIRM OF FALSE POSITIVE. THE REPORTED ISSUE WAS UNABLE TO BE CONFIRMED. THERE ARE NO CURRENT TRENDS AGAINST FALSE POSITIVE. BD QUALITY WILL CONTINUE TO CLOSELY 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 KIT FLU VERITOR SYSTEM 30 TEST JAPAN 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. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THIS IS A REPORT ABOUT A FALSE POSITIVE. ACCORDING TO THE CUSTOMER'S REPORT, THE RESULT APPEARS TO BE POSITIVE WITH A SAMPLE WHICH IS SUPPOSEDLY NEGATIVE."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING KIT FLU VERITOR SYSTEM 30 TEST JAPAN 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. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THIS IS A REPORT ABOUT A FALSE POSITIVE. ACCORDING TO THE CUSTOMER'S REPORT, THE RESULT APPEARS TO BE POSITIVE WITH A SAMPLE WHICH IS SUPPOSEDLY NEGATIVE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2198492 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 Unknown