BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD KIT FLU A+B 30 TEST PHYSICIAN VERITOR

    MDR report key: 11276754 · Received February 3, 2021

    Report

    Report Number
    3006948883-2021-00183
    Event Type
    Malfunction
    Date Received
    February 3, 2021
    Date of Event
    January 4, 2021
    Report Date
    September 16, 2021
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    Product Code
    GNX
    UDI-DI
    00382902560456
    PMA / PMN Number
    K132692
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: THIS STATEMENT IS TO SUMMARIZE THE INVESTIGATION RESULTS REGARDING THE COMPLAINT THAT ALLEGES FALSE POSITIVE RESULTS WHEN USING KIT FLU A+B 30 TEST PHYSICIAN VERITOR (MN# 256045), BATCH NUMBER 0093792. 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. THE ROOT CAUSE COULD NOT BE IDENTIFIED. BD QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING WITH BD KIT FLU A+B 30 TEST PHYSICIAN VERITOR¿ 5 FALSE POSITIVE RESULTS WERE OBTAINED ON ASYMPTOMATIC PATIENTS. CONFIRMATORY TESTING WAS PERFORMED USING PCR TEST METHOD AND THE RESULTS WERE NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE LOT #: 0093792 WAS REPORTED, HOWEVER, THIS IS NOT A LOT# MANUFACTURED FOR THIS PRODUCT. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE TESTING WITH BD KIT FLU A+B 30 TEST PHYSICIAN VERITOR¿ 5 FALSE POSITIVE RESULTS WERE OBTAINED ON ASYMPTOMATIC PATIENTS. CONFIRMATORY TESTING WAS PERFORMED USING PCR TEST METHOD AND THE RESULTS WERE NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173770 BD KIT FLU A+B 30 TEST PHYSICIAN VERITOR DEVICES DETECTING INFLUENZA A, B, & C VIRUS ANTIGENS GNX BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 256045 0093792 00382902560456

    Patients

    Seq Age Sex Outcome Treatment
    1