BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD RAPID DETECTION OF SARS-COV-2 VERITOR

    MDR report key: 12229331 · Received July 27, 2021

    Report

    Report Number
    1119779-2021-01219
    Event Type
    Malfunction
    Date Received
    July 27, 2021
    Date of Event
    June 25, 2021
    Report Date
    December 10, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    QKP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY THIS STATEMENT SUMMARIZES THE INVESTIGATION RESULTS REGARDING YOUR COMPLAINT THAT ALLEGES FALSE POSITIVE RESULTS WHEN USING KIT RAPID DETECTION OF SARS-COV-2 VERITOR (MATERIAL # 256082), BATCH NUMBER 1090845. 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 WAS PERFORMED ON THE BATCH NUMBER PROVIDED AND NO RELEVANT ISSUE WAS FOUND. RETENTION SAMPLE TESTING WAS NOT DONE BECAUSE THE MATERIAL WAS PAST ITS EXPIRATION DATE. BD MAKES NO CLAIMS ON EXPIRED PRODUCTS AND STABILITY STUDIES HAVE SHOWN THE USE OF EXPIRED MATERIALS MAY AFFECT THE SENSITIVITY OF THE ASSAY. THEREFORE, MATERIALS PAST EXPIRY WILL NOT BE TESTED. A TREND WAS IDENTIFIED FOR FALSE POSITIVE RESULTS. BASED ON THE TREND, A CORRECTIVE AND PREVENTIVE ACTION (CAPA) 1878253 WAS INITIATED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING FOR SARS COV-2 FALSE POSITIVE RESULTS WERE OBTAINED. REPEAT TESTS WERE PERFORMED USING PCR AND THE RESULTS WERE NEGATIVE. THE CUSTOMER STATED THERE WAS NO PATIENT IMPACT. EUA#: (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " CUSTOMER PROBLEM: CUSTOMER REPORTED THREE LINES ON THE TEST DEVICE WHICH WAS UNUSUAL SINCE THEY STARTED USING BD VERITOR. BD VERITOR DISPLAYED A POSITIVE TEST RESULT WITH THAT TEST DEVICE BUT FOLLOW UP PCR RESULT WAS NEGATIVE. "

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. 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 · 1

    IT WAS REPORTED WHILE TESTING FOR SARS COV-2 FALSE POSITIVE RESULTS WERE OBTAINED. REPEAT TESTS WERE PERFORMED USING PCR AND THE RESULTS WERE NEGATIVE. THE CUSTOMER STATED THERE WAS NO PATIENT IMPACT. EUA#: (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER PROBLEM: CUSTOMER REPORTED THREE LINES ON THE TEST DEVICE WHICH WAS UNUSUAL SINCE THEY STARTED USING BD VERITOR. BD VERITOR DISPLAYED A POSITIVE TEST RESULT WITH THAT TEST DEVICE BUT FOLLOW UP PCR RESULT WAS NEGATIVE. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1127981 BD RAPID DETECTION OF SARS-COV-2 VERITOR CORONAVIRUS ANTIGEN DETECTION SYSTEM QKP BECTON, DICKINSON & CO. (SPARKS) 1090714

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown