BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD RAPID DETECTION OF SARS-COV-2 VERITOR¿

    MDR report key: 12282289 · Received August 5, 2021

    Report

    Report Number
    1119779-2021-01311
    Event Type
    Malfunction
    Date Received
    August 5, 2021
    Date of Event
    July 12, 2021
    Report Date
    October 25, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    QKP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    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 FALSE POSITIVE RESULTS WHEN USING KIT RAPID DETECTION OF SARS-COV-2 VERITOR (MATERIAL # 256082), BATCH NUMBER 1132561. 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. THE REPORTED ISSUE WAS UNABLE TO BE CONFIRMED. HOWEVER, THERE IS A TREND AGAINST FALSE POSITIVE RESULTS. BD HAS INITIATED CAPA#1878253 TO FURTHER INVESTIGATE. THE ROOT CAUSE COULD NOT BE IDENTIFIED. BD QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING FOR SARS-COV-2 4 FALSE POSITIVE RESULTS WERE OBTAINED. CONFIRMATORY TESTING WAS PERFORMED USING PCR TEST METHOD AND THE RESULTS WERE NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT. EUA # (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: OPERATION AT INPATIENT VISITORS ART CENTRE, 3 ART RESULTS SHOWED COV2 + AT ANALYZER 1 WITH ONLY THE C LINE APPEAR ON THE CARTRIDGE, USER INSERTED THESE 3 CARTRIDGES IN TO ANALYZER 2 , RESULT SHOW COV2 + FOR ALL THE 3 CARTRIDGES AS WELL. 1 ART RESULT SHOWED COV2 + AT ANALYZER 1 WITH C LINE AND VERY FAINT RED LINE AT T ZONE, USER INSERTED THIS 1 CARTRIDGE IN TO THE ANALYZER 2, RESULT SHOW COV2 +. ALL THE 4 VISITORS BEEN SENT FOR PCR TEST, WITH THE PCR RESULT SHOWED NEGATIVE.

    Additional Manufacturer Narrative · 1

    EUA # (B)(4). 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 · 1

    IT WAS REPORTED WHILE TESTING FOR SARS-COV-2 4 FALSE POSITIVE RESULTS WERE OBTAINED. CONFIRMATORY TESTING WAS PERFORMED USING PCR TEST METHOD AND THE RESULTS WERE NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT. EUA # (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: OPERATION AT INPATIENT VISITORS ART CENTRE, 3 ART RESULTS SHOWED COV2 + AT ANALYZER 1 WITH ONLY THE C LINE APPEAR ON THE CARTRIDGE, USER INSERTED THESE 3 CARTRIDGES IN TO ANALYZER 2 , RESULT SHOW COV2 + FOR ALL THE 3 CARTRIDGES AS WELL. 1 ART RESULT SHOWED COV2 + AT ANALYZER 1 WITH C LINE AND VERY FAINT RED LINE AT T ZONE, USER INSERTED THIS 1 CARTRIDGE IN TO THE ANALYZER 2, RESULT SHOW COV2 +. ALL THE 4 VISITORS BEEN SENT FOR PCR TEST, WITH THE PCR RESULT SHOWED NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1181966 BD RAPID DETECTION OF SARS-COV-2 VERITOR¿ CORONAVIRUS ANTIGEN DETECTION SYSTEM QKP BECTON, DICKINSON & CO. (SPARKS) 1132561

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown