BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIT FLU A+B 30 TEST HOSPITAL VERITOR

    MDR report key: 12197316 · Received July 20, 2021

    Report

    Report Number
    3006948883-2021-00814
    Event Type
    Malfunction
    Date Received
    July 20, 2021
    Date of Event
    June 20, 2021
    Report Date
    September 23, 2021
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    Product Code
    PSZ
    UDI-DI
    00382902560418
    PMA / PMN Number
    K133138
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: THIS IS TO SUMMARIZE THE INVESTIGATION RESULTS FOR CUSTOMER COMPLAINTS ALLEGING FALSE POSITIVE OR DISCREPANT RESULTS WHEN USING THE KIT FLU A+B 30 TEST HOSPITAL VERITOR (MATERIAL # 256041) BATCH NUMBER 0040169. 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. THE REPORTED ISSUE WAS UNABLE TO BE CONFIRMED. NO TREND AGAINST FALSE POSITIVE RESULTS WAS IDENTIFIED. THE ROOT CAUSE COULD NOT BE IDENTIFIED. BD QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING KIT FLU A+B 30 TEST HOSPITAL VERITOR 5 FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. A BIOFIRE VIRAL PANEL WAS USED TO CONFIRM THE RESULTS AS FALSE POSITIVES. THE CUSTOMER STATED THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " IT WAS REPORTED THAT 5 FALSE POSITIVES. "

    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 FLU A+B 30 TEST HOSPITAL VERITOR 5 FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. A BIOFIRE VIRAL PANEL WAS USED TO CONFIRM THE RESULTS AS FALSE POSITIVES. THE CUSTOMER STATED THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " IT WAS REPORTED THAT 5 FALSE POSITIVES. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1097043 KIT FLU A+B 30 TEST HOSPITAL VERITOR DEVICES DETECTING INFLUENZA A, B, AND C VIRUS ANTIGENS PSZ BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 256041 0040169 00382902560418

    Patients

    Seq Age Sex Outcome Treatment
    1