BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD RAPID DETECTION OF SARS-COV-2 VERITOR

    MDR report key: 11809098 · Received May 11, 2021

    Report

    Report Number
    1119779-2021-00813
    Event Type
    Malfunction
    Date Received
    May 11, 2021
    Date of Event
    November 12, 2020
    Report Date
    December 6, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    QKP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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 YOUR COMPLAINT THAT ALLEGES INVALID RESULT WHEN USING KIT RAPID DETECTION OF SARS-COV-2 VERITOR (MATERIAL # 256082), BATCH NUMBER 0310425. BD QUALITY PERFORMS A SYSTEMATIC APPROACH TO INVESTIGATE INVALID RESULT COMPLAINTS. THIS APPROACH INVOLVES REVIEW OF MANUFACTURING BATCH HISTORY RECORDS, TESTING OF RETENTION SAMPLES, AND TESTING OF CUSTOMER RETURNED SAMPLES, IF APPLICABLE. A BHR REVIEW WAS PERFORMED AND NO ISSUES WERE IDENTIFIED. RETENTION AND RETURNED SAMPLE ANALYSIS COULD NOT BE PERFORMED. A TREND FOR FALSE POSITIVE RESULTS WAS IDENTIFIED AND BD HAS INITIATED CAPA (CORRECTIVE AND PREVENTIVE ACTION) # 1878253 TO FURTHER INVESTIGATE.

    Additional Manufacturer Narrative · 0

    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 · 0

    IT WAS REPORTED WHILE TESTING FOR SARS COV-2 A FALSE POSITIVE RESULT WAS OBTAINED. A REPEAT TEST WAS PERFORMED USING PCR AND THE RESULT WAS NEGATIVE. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. EUA#: EUA(B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " IT WAS REPORTED THAT CUSTOMER IS REPORTING 1 FP (B)(6) ,2020 REPEAT. BOTH HAD PCR TWO LOT NUMBERS ORDERED EARLY, HAD SOME INCONSISTENT RESULTS, DOING RAPID COVID BACKING UP WITH PCR, RAPID WAS POSITIVE AND PCR WAS NEGATIVE, STOPPED USING VERITOR FOR COVID DUE TO CONCERNS.SYMPTOMATIC PATIENT TESTED POSITIVE ON VERITOR AND NEGATIVE ON PCR. SEVERAL TIMES THE RAPID COVID TEST WAS POSITIVE AND PCR WAS NEGATIVE SO PHYSICIANS STOPPED USING THE VERITOR COVID TEST. "

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING FOR SARS COV-2 A FALSE POSITIVE RESULT WAS OBTAINED. A REPEAT TEST WAS PERFORMED USING PCR AND THE RESULT WAS NEGATIVE. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. (B)(4) THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " IT WAS REPORTED THAT CUSTOMER IS REPORTING 1 FP (B)(6) 2020 AND (B)(6) 2020 REPEAT. BOTH HAD PCR TWO LOT NUMBERS ORDERED EARLY, HAD SOME INCONSISTENT RESULTS, DOING RAPID COVID BACKING UP WITH PCR, RAPID WAS POSITIVE AND PCR WAS NEGATIVE, STOPPED USING VERITOR FOR COVID DUE TO CONCERNS.SYMPTOMATIC PATIENT TESTED POSITIVE ON VERITOR AND NEGATIVE ON PCR. SEVERAL TIMES THE RAPID COVID TEST WAS POSITIVE AND PCR WAS NEGATIVE SO PHYSICIANS STOPPED USING THE VERITOR COVID TEST. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703391 BD RAPID DETECTION OF SARS-COV-2 VERITOR CORONAVIRUS ANTIGEN DETECTION SYSTEM QKP BECTON, DICKINSON & CO. (SPARKS) 0310425

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown