BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD RAPID DETECTION OF SARS-COV-2 VERITOR¿

    MDR report key: 12800532 · Received November 11, 2021

    Report

    Report Number
    1119779-2021-01804
    Event Type
    Malfunction
    Date Received
    November 11, 2021
    Date of Event
    October 15, 2021
    Report Date
    January 27, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    QKP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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 TEST DEVICE NEGATIVE AFTER 15 MINUTES OF INCUBATION AND POSITIVE AFTER 18 MINUTES OF INCUBATION WHEN USING KIT RAPID DETECTION OF SARS-COV-2 VERITOR (MATERIAL # 256082), BATCH NUMBER 1153341. BD QUALITY PERFORMS A SYSTEMATIC APPROACH TO INVESTIGATE TEST DEVICE NEGATIVE AFTER 15 MINUTES OF INCUBATION AND POSITIVE AFTER 18 MINUTES OF INCUBATION COMPLAINTS. THIS APPROACH INVOLVES REVIEW OF MANUFACTURING BATCH HISTORY RECORDS, TESTING OF RETENTION SAMPLES, AND TESTING OF CUSTOMER RETURNED SAMPLES, IF APPLICABLE. A BATCH REVIEW WAS PERFORMED FOR THE NUMBER PROVIDED. THE REPORTED ISSUE WAS UNABLE TO BE CONFIRMED. THE RETENTION TESTING COULD NOT BE TESTED AS THEY ARE EXPIRED. THERE ARE NO CURRENT TRENDS AGAINST TEST DEVICE NEGATIVE AFTER 15 MINUTES OF INCUBATION AND POSITIVE AFTER 18 MINUTES OF INCUBATION WAS IDENTIFIED. BD QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS. H3 OTHER TEXT : SEE H.10.

    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 WHILE TESTING WITH BD RAPID DETECTION OF SARS-COV-2 VERITOR¿ THE TEST WAS NEGATIVE AFTER 15 MIN AND THEN POSITIVE AFTER 18 MIN. THERE WAS NO REPORT OF CONFIRMATORY TESTING OR PATIENT IMPACT. EUA # (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: THE SAME BD VERITOR TEST DEVICE WAS NEGATIVE AFTER 15 MINUTES OF INCUBATION AND POSITIVE AFTER 18 MINUTES OF INCUBATION.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING WITH BD RAPID DETECTION OF SARS-COV-2 VERITOR¿ THE TEST WAS NEGATIVE AFTER 15 MIN AND THEN POSITIVE AFTER 18 MIN. THERE WAS NO REPORT OF CONFIRMATORY TESTING OR PATIENT IMPACT. EUA # (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: THE SAME BD VERITOR TEST DEVICE WAS NEGATIVE AFTER 15 MINUTES OF INCUBATION AND POSITIVE AFTER 18 MINUTES OF INCUBATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1699329 BD RAPID DETECTION OF SARS-COV-2 VERITOR¿ CORONAVIRUS ANTIGEN DETECTION SYSTEM QKP BECTON, DICKINSON & CO. (SPARKS) 1153341

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown