BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD RAPID DETECTION OF SARS-COV-2 VERITOR¿

    MDR report key: 11395227 · Received March 1, 2021

    Report

    Report Number
    3006948883-2021-00270
    Event Type
    Malfunction
    Date Received
    March 1, 2021
    Date of Event
    February 16, 2021
    Report Date
    September 16, 2021
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    Product Code
    QKP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 CE (MATERIAL # 256089), BATCH NUMBER 1010086. 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 AND TESTING WERE PERFORMED ON THE BATCH NUMBER PROVIDED AND NO RELEVANT ISSUE WAS FOUND. THE COMPLAINT WAS UNABLE TO BE CONFIRMED VIA THE RETAIN SAMPLES. A PHOTO WAS PROVIDED. THE COMPLAINT ISSUE COULD NOT BE CONFIRMED VIA THE PHOTO. THE ROOT CAUSE COULD NOT BE IDENTIFIED. A TREND ANALYSIS FOR FALSE POSITIVE WAS CONDUCTED, A TREND WAS IDENTIFIED FOR FALSE POSITIVE. BASED ON THE TREND, A CORRECTIVE AND PREVENTIVE ACTION (CAPA) 1878253 WAS INITIATED. BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS. THERE WERE NO CORRECTIVE ACTIONS TAKEN AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING FOR SARS-COV-2 2 FALSE POSITIVE RESULTS WERE OBTAINED ON SAME PATIENT TWO WEEKS APART. CONFIRMATORY TESTING WAS PERFORMED USING PCR TEST METHOD AND THE RESULTS WERE NEGATIVE. THE CUSTOMER STATED THE PATIENT TESTED WAS ASYMPTOMATIC. THIS TEST IS NOT INTENDED FOR USE ON ASYMPTOMATIC PATIENTS AND WAS THEREFORE USED OFF LABEL. THERE WAS NO REPORT OF PATIENT IMPACT. EUA #(B)(4).

    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 2 FALSE POSITIVE RESULTS WERE OBTAINED ON SAME PATIENT TWO WEEKS APART. CONFIRMATORY TESTING WAS PERFORMED USING PCR TEST METHOD AND THE RESULTS WERE NEGATIVE. THE CUSTOMER STATED THE PATIENT TESTED WAS ASYMPTOMATIC. THIS TEST IS NOT INTENDED FOR USE ON ASYMPTOMATIC PATIENTS AND WAS THEREFORE USED OFF LABEL. THERE WAS NO REPORT OF PATIENT IMPACT. EUA # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288406 BD RAPID DETECTION OF SARS-COV-2 VERITOR¿ CORONAVIRUS ANTIGEN DETECTION SYSTEM QKP BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 1010086

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown