BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD RAPID DETECTION OF SARS-COV-2 VERITOR¿

    MDR report key: 12729280 · Received November 1, 2021

    Report

    Report Number
    1119779-2021-01741
    Event Type
    Malfunction
    Date Received
    November 1, 2021
    Date of Event
    October 4, 2021
    Report Date
    February 2, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    QKP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2021-10-11. H6: INVESTIGATION SUMMARY THIS SUMMARIZES THE INVESTIGATION RESULTS REGARDING YOUR COMPLAINT THAT ALLEGES TWO FALSE POSITIVE RESULTS WHEN USING KIT RAPID DETECTION OF SARS-COV-2 VERITOR (MATERIAL # 256082), BATCH NUMBER 1213540. THE PATIENT¿S SURGERY WAS RESCHEDULED PENDING PCR RESULTS. 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 EXPIRED. 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, EXPIRED MATERIALS WILL NOT BE TESTED. RETURNED SAMPLE DEVICES WERE TESTED AND HAD NORMAL INTENDED RESULTS. 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 H10.

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE LOT #: AN INVALID LOT # 213540, WAS PROVIDED BY THE INITIAL REPORTER. 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 · 0

    IT WAS REPORTED THAT A FALSE POSITIVE TEST RESULT ON A BD RAPID DETECTION OF SARS-COV-2 VERITOR¿ WAS OBERSVED BY LABORATORY PERSONNEL. CONFIRMATORY PCR TESTING WAS PERFORMED. THERE WAS NO REPORT OF PATIENT IMPACT. EUA # (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ONE OF THE PATIENTS HAD TO WAIT FOR PCR RESULTS SO THEY RESCHEDULED THE SURGERY. IT WAS NOT LIFE THREATENING BUT THE CUSTOMER MENTIONED THAT THE PATIENT WAS IN PAIN AND IF THE SURGERY DONE AS SCHEDULED THAT WOULD HELP WITH THE PAIN BUT THE PATIENT HAD TO WAIT IN PAIN FOR PCR RESULTS BEFORE THEY RESCHEDULED THE SURGERY. THE PATIENT WAS NOT UNDER ANESTHESIA. IS THE CUSTOMER REPORTING A FALSE POSITIVE OR FALSE NEGATIVE? FALSE POS. WHAT TYPE OF REFERENCE METHOD WAS USED TO CONFIRM THE RESULT (PCR, VIRAL CULTURE, ETC)? PCR. CUSTOMER REPORTS 2 FALSE POSITIVE RESULTS ON COVID TEST 256082, LOT# LOT 1213540, EXP: 12/16/22.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A FALSE POSITIVE TEST RESULT ON A BD RAPID DETECTION OF SARS-COV-2 VERITOR¿ WAS OBSERVED BY LABORATORY PERSONNEL. CONFIRMATORY PCR TESTING WAS PERFORMED. THERE WAS NO REPORT OF PATIENT IMPACT. EUA # (B)(4) THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ONE OF THE PATIENTS HAD TO WAIT FOR PCR RESULTS SO THEY RESCHEDULED THE SURGERY. IT WAS NOT LIFE THREATENING BUT THE CUSTOMER MENTIONED THAT THE PATIENT WAS IN PAIN AND IF THE SURGERY DONE AS SCHEDULED THAT WOULD HELP WITH THE PAIN BUT THE PATIENT HAD TO WAIT IN PAIN FOR PCR RESULTS BEFORE THEY RESCHEDULED THE SURGERY. THE PATIENT WAS NOT UNDER ANESTHESIA. IS THE CUSTOMER REPORTING A FALSE POSITIVE OR FALSE NEGATIVE? FALSE POS. WHAT TYPE OF REFERENCE METHOD WAS USED TO CONFIRM THE RESULT (PCR, VIRAL CULTURE, ETC)? PCR CUSTOMER REPORTS 2 FALSE POSITIVE RESULTS ON COVID TEST (B)(6), LOT# 1213540, EXP: (B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1627301 BD RAPID DETECTION OF SARS-COV-2 VERITOR¿ CORONAVIRUS ANTIGEN DETECTION SYSTEM QKP BECTON, DICKINSON & CO. (SPARKS) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown