BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 12625557 · Received October 13, 2021

    Report

    Report Number
    3006948883-2021-00964
    Event Type
    Malfunction
    Date Received
    October 13, 2021
    Date of Event
    September 13, 2021
    Report Date
    January 7, 2022
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    Product Code
    QMN
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.4. MEDICAL DEVICE LOT #: 1182888. D.4. MEDICAL DEVICE EXPIRATION DATE: 10/10/2022. H.4. DEVICE MANUFACTURE DATE: 6/12/2021. H.6. INVESTIGATION: THIS STATEMENT 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 1182888 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 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE TESTING FOR SARS-COV-2 ON THE BD VERITOR¿ SARS-COV-2 AND FLU A+B, ONE FALSE POSITIVE RESULT WAS OBTAINED. PCR TESTING WAS USED TO CONFIRM THE RESULT WAS NEGATIVE. ERRONEOUS RESULTS WERE REPORTED TO DOCTORS. THE PATIENT DID NOT RECEIVE TREATMENT AS A RESULT, AND HAD NO ADVERSE EFFECTS/IMPACTS. EUA#:(B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTS FALSE POSITIVES WITH 256088." "ON (B)(6) 2021, THEY USED A NEW LOT, #1182888, WHICH PRODUCED ONE FALSE POSITIVE... ON (B)(6) 2021, PCR ONLY, WAS THE CONFIRMATORY TEST USED." "1. HOW MANY SPECIMENS WERE DISCREPANT (FP OR FN)? 1. 2. WHAT IS THE COLLECTION DATE AND TIME FOR EACH DISCREPANT SAMPLE? (B)(6) 2021. 3. WHAT TYPE OF REFERENCE METHOD WAS USED TO CONFIRM THE RESULT (PCR, VIRAL CULTURE, ETC)? PCR. 4. WAS THE PATIENT(S) SYMPTOMATIC WHEN TESTED ON THE VERITOR PLUS ANALYZER? Y. 5. HOW THE TEST IS BEING USED ¿ 6. ASYMPTOMATIC PATIENTS OR DR. RECOMMENDED TESTING? N. 7. DID YOU VISUALLY INTERPRET THE RESULT OR DID YOU INSERT INTO THE ANALYZER TO DETERMINE THE RESULT? USED DEVICE 8. WERE THE KIT QC SWABS TESTED AND IF SO, DID THEY PASS? Y. 9. WAS THERE PATIENT IMPACT AS A RESULT OF THE FALSE RESULT? Y. 10. IF YES, WERE RESULTS REPORTED TO A MEDICAL DOCTOR? Y. 11. IF YES, DID THE PATIENT RECEIVE TREATMENT? N. 12. IF YES, ANY ADVERSE EFFECT ON THE PATIENT? N.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE TESTING FOR SARS-COV-2 ON THE BD VERITOR¿ SARS-COV-2 AND FLU A+B, ONE FALSE POSITIVE RESULT WAS OBTAINED. PCR TESTING WAS USED TO CONFIRM THE RESULT WAS NEGATIVE. ERRONEOUS RESULTS WERE REPORTED TO DOCTORS. THE PATIENT DID NOT RECEIVE TREATMENT AS A RESULT, AND HAD NO ADVERSE EFFECTS/IMPACTS. EUA#: (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTS FALSE POSITIVES WITH 256088." "ON (B)(6) 2021, THEY USED A NEW LOT, #1182888, WHICH PRODUCED ONE FALSE POSITIVE. ON (B)(6) 2021, PCR ONLY, WAS THE CONFIRMATORY TEST USED." " HOW MANY SPECIMENS WERE DISCREPANT (FP OR FN)? 1. WHAT IS THE COLLECTION DATE AND TIME FOR EACH DISCREPANT SAMPLE? (B)(6) 2021. WHAT TYPE OF REFERENCE METHOD WAS USED TO CONFIRM THE RESULT (PCR, VIRAL CULTURE, ETC)? PCR. WAS THE PATIENT(S) SYMPTOMATIC WHEN TESTED ON THE VERITOR PLUS ANALYZER? Y. HOW THE TEST IS BEING USED ¿ N/A. ASYMPTOMATIC PATIENTS OR DR. RECOMMENDED TESTING? N/A. DID YOU VISUALLY INTERPRET THE RESULT OR DID YOU INSERT INTO THE ANALYZER TO DETERMINE THE RESULT? USED DEVICE. WERE THE KIT QC SWABS TESTED AND IF SO, DID THEY PASS? Y. WAS THERE PATIENT IMPACT AS A RESULT OF THE FALSE RESULT? Y. IF YES, WERE RESULTS REPORTED TO A MEDICAL DOCTOR? Y. IF YES, DID THE PATIENT RECEIVE TREATMENT? N. IF YES, ANY ADVERSE EFFECT ON THE PATIENT? N."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1520550 BD VERITOR¿ SARS-COV-2 AND FLU A+B NOT CLASSIFIED QMN BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 1182888

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown