BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD RAPID DETECTION OF SARS-COV-2 VERITOR¿

    MDR report key: 12848941 · Received November 19, 2021

    Report

    Report Number
    3006948883-2021-01009
    Event Type
    Malfunction
    Date Received
    November 19, 2021
    Date of Event
    September 21, 2021
    Report Date
    January 24, 2022
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    Product Code
    QKP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY THIS STATEMENT IS TO SUMMARIZE THE INVESTIGATION RESULTS REGARDING THE COMPLAINT THAT ALLEGES FALSE POSITIVE WHEN USING KIT RAPID DETECTION OF SARS-COV-2 VERITOR CE (MATERIAL # 256089), BATCH NUMBER 1091111. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). 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 WHILE TESTING WITH BD RAPID DETECTION OF SARS-COV-2 VERITOR¿ A FALSE POSITIVE RESULT WAS OBTAINED. THERE WAS NO REPORT OF CONFIRMATORY TESTING. THERE WAS NO REPORT OF PATIENT IMPACT. EUA # (B)(4). THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: HE HAS HAD TO SELF-ISOLATE AND QUARANTINE DUE TO ONE FP RESULT WITH 256082 - WHICH ULTIMATELY RESULTS IN HIM NOT BEING ABLE TO TRAVEL. IT WAS REPORTED THAT THERE WAS ONE FALSE POSITIVE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING WITH BD RAPID DETECTION OF SARS-COV-2 VERITOR¿ A FALSE POSITIVE RESULT WAS OBTAINED. THERE WAS NO REPORT OF CONFIRMATORY TESTING. THERE WAS NO REPORT OF PATIENT IMPACT. (B)(4). THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: HE HAS HAD TO SELF-ISOLATE AND QUARANTINE DUE TO ONE FP RESULT WITH 256082 - WHICH ULTIMATELY RESULTS IN HIM NOT BEING ABLE TO TRAVEL. IT WAS REPORTED THAT THERE WAS ONE FALSE POSITIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1744067 BD RAPID DETECTION OF SARS-COV-2 VERITOR¿ CORONAVIRUS ANTIGEN DETECTION SYSTEM QKP BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 1091111

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown