BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VERITOR¿ SARS-COV-2 AND FLU A+B

    MDR report key: 12807866 · Received November 12, 2021

    Report

    Report Number
    3006948883-2021-01000
    Event Type
    Malfunction
    Date Received
    November 12, 2021
    Date of Event
    October 18, 2021
    Report Date
    February 2, 2022
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    Product Code
    QMN
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY THIS SUMMARIZES THE INVESTIGATION RESULTS REGARDING YOUR COMPLAINT THAT ALLEGES FLU A RESULTS WERE POSITIVE WHEN USING KIT (RAPID DETECTION OF SARS-COV-2 & FLU A+B (MATERIAL # 256088), BATCH NUMBER 1193294 AND NEGATIVE WITH A COMPETITOR'S RAPID ID KIT (QUIDEL QUIKVIEW FLU TEST). 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 AND NO RELEVANT ISSUE WAS FOUND. THE COMPLAINT WAS UNABLE TO BE CONFIRMED VIA THE RETAIN SAMPLES. THE ROOT CAUSE COULD NOT BE IDENTIFIED. A TREND ANALYSIS FOR FALSE POSITIVE WAS CONDUCTED, NO ADVERSE TREND WAS IDENTIFIED. BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 4 BD VERITOR¿ SARS-COV-2 AND FLU A+B GAVE FALSE POSITIVE TEST RESULTS. CONFIRMATORY TESTING WAS PERFORMED. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. EUA# (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 3 PATIENTS TESTED POS FOR FLU A; THE DOCTOR DOUBTED THESE RESULTS, AND TESTED HIMSELF, TWICE - BOTH RESULTS CAME POSITIVE FOR FLU A. IN ORDER TO DOUBLE CHECK HIS RESULT HE TESTED HIMSELF ON THE QUIDEL, AND IT CAME BACK NEGATIVE FOR FLU.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 4 BD VERITOR¿ SARS-COV-2 AND FLU A+B GAVE FALSE POSITIVE TEST RESULTS. CONFIRMATORY TESTING WAS PERFORMED. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 3 PATIENTS TESTED POS FOR FLU A; THE DOCTOR DOUBTED THESE RESULTS, AND TESTED HIMSELF, TWICE - BOTH RESULTS CAME POSITIVE FOR FLU A. IN ORDER TO DOUBLE CHECK HIS RESULT HE TESTED HIMSELF ON THE QUIDEL, AND IT CAME BACK NEGATIVE FOR FLU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1701516 BD VERITOR¿ SARS-COV-2 AND FLU A+B NOT CLASSIFIED QMN BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 1193294

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown