BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD KIT FLU A+B 30 TEST PHYSICIAN VERITOR

    MDR report key: 12937547 · Received December 6, 2021

    Report

    Report Number
    1119779-2021-01917
    Event Type
    Malfunction
    Date Received
    December 6, 2021
    Date of Event
    October 31, 2021
    Report Date
    January 27, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    PSZ
    UDI-DI
    00382902560456
    PMA / PMN Number
    K112277
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: 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), INVALID BATCH NUMBER 0051984 WAS REPORTED. 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 INVALID BATCH NUMBER 0051984 WAS PROVIDED. PROVIDED BATCH NUMBER 0051984 IS INVALID BECAUSE THE BATCH IS NOT ASSOCIATED WITH MATERIAL 256045. THE REPORTED ISSUE WAS UNABLE TO BE CONFIRMED. NO TREND AGAINST FALSE POSITIVE RESULTS WAS IDENTIFIED. BD QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS. H3 OTHER TEXT : SEE H.10.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD KIT FLU A+B 30 TEST PHYSICIAN VERITOR 2 FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. A BIOFIRE PCR TEST WAS USED TO CONFIRM THE RESULTS AS FALSE POSITIVES. 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: "CUSTOMER SAYS SHE HAS BEEN GETTING FP TESTS ON THE RAPID DETECTION OF FLU A/B TESTS".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD KIT FLU A+B 30 TEST PHYSICIAN VERITOR 2 FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. A BIOFIRE PCR TEST WAS USED TO CONFIRM THE RESULTS AS FALSE POSITIVES. 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: "CUSTOMER SAYS SHE HAS BEEN GETTING FP TESTS ON THE RAPID DETECTION OF FLU A/B TESTS"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1838367 BD KIT FLU A+B 30 TEST PHYSICIAN VERITOR DEVICES DETECTING INFLUENZA A, B, AND C VIRUS ANTIGENS PSZ BECTON, DICKINSON & CO. (SPARKS) 256045 0051984 00382902560456

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown