BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VERITOR ¿ SARS-COV-2 & FLU A+B

    MDR report key: 12984849 · Received December 13, 2021

    Report

    Report Number
    3006948883-2021-01023
    Event Type
    Malfunction
    Date Received
    December 13, 2021
    Date of Event
    November 17, 2021
    Report Date
    January 27, 2022
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    Product Code
    QMN
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: THIS SUMMARIZES THE INVESTIGATION RESULTS REGARDING THE COMPLAINT THAT ALLEGES GETTING NEGATIVE RESULTS WHEN USING KIT (RAPID DETECTION OF SARS-COV-2 & FLU A+B (MATERIAL # 256088), BATCH NUMBER 1193294 AND POSITIVE RESULTS WHEN USING A FLU A KIT. BD QUALITY PERFORMS A SYSTEMATIC APPROACH TO INVESTIGATE ERRONEOUS RESULTS 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 ERRONEOUS RESULTS WAS CONDUCTED, NO ADVERSE TREND WAS IDENTIFIED. BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS. THERE WERE NO CORRECTIVE ACTIONS TAKEN AT THIS TIME. H3 OTHER TEXT : SEE H.10.

    Additional Manufacturer Narrative · 0

    (B)(4). 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 WHILE TESTING WITH BD VERITOR ¿ SARS-COV-2 & FLU A+B, DISCREPANT RESULTS WERE OBTAINED. RESULT WAS NEGATIVE; REPEAT TEST WAS PERFORMED ON KIT FLU A+B 30 TEST PHYSICIAN VERITOR AND THE RESULT WAS POSITIVE. THERE WAS NO REPORT OF PATIENT IMPACT. EUA #(B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS THAT SHE GET POSITIVE FLU A ON FLU KIT LOT# 0015987, EXP: 1/5/23 BUT NEGATIVE FLU A ON TRIPLEX ASSAY LOT# 1193294, EXP: 8/2/22.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING WITH BD VERITOR ¿ SARS-COV-2 & FLU A+B, DISCREPANT RESULTS WERE OBTAINED. RESULT WAS NEGATIVE; REPEAT TEST WAS PERFORMED ON KIT FLU A+B 30 TEST PHYSICIAN VERITOR AND THE RESULT WAS POSITIVE. THERE WAS NO REPORT OF PATIENT IMPACT. (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS THAT SHE GET POSITIVE FLU A ON FLU KIT LOT# 0015987, EXP: 1/5/23 BUT NEGATIVE FLU A ON TRIPLEX ASSAY LOT# 1193294, EXP: 8/2/22.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1885322 BD VERITOR ¿ SARS-COV-2 & FLU A+B NOT CLASSIFIED QMN BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 1193294

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown