BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD RAPID DETECTION OF SARS-COV-2 VERITOR¿

    MDR report key: 10830052 · Received November 12, 2020

    Report

    Report Number
    1119779-2020-00991
    Event Type
    Malfunction
    Date Received
    November 12, 2020
    Date of Event
    October 29, 2020
    Report Date
    October 26, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    QKP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THIS MEMO IS TO SUMMARIZE THE INVESTIGATION RESULTS REGARDING YOUR COMPLAINTS THAT ALLEGES FALSE NEGATIVE OR DISCREPANT RESULTS WHEN USING KIT BD VERITOR FOR RAPID DETECTION OF SARS-COV-2 (MN# 256082), BATCH NUMBER 0173444. BD QUALITY PERFORMS A SYSTEMATIC APPROACH TO INVESTIGATE FALSE NEGATIVE COMPLAINTS. THIS APPROACH INVOLVES REVIEW OF MANUFACTURING BATCH HISTORY RECORDS, TESTING OF RETENTION SAMPLES, AND TESTING OF CUSTOMER RETURNED SAMPLES IF APPLICABLE. A BATCH REVIEW WAS PERFORMED FOR THE NUMBER PROVIDED. THE REPORTED ISSUE WAS UNABLE TO BE CONFIRMED. THE RETENTION TESTING COULD NOT BE TESTED AS THEY ARE EXPIRED. 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 A FALSE NEGATIVE RESULT WAS OBTAINED. REPEAT TEST WAS PERFORMED USING A PCR TEST METHOD AND THE RESULT WAS POSITIVE. THERE WAS NO PATIENT IMPACT AS STAFF MEMBER WAS SENT HOME TO QUARANTINE WHEN SYMPTOMS DEVELOPED. EUA # (B)(4)

    Additional Manufacturer Narrative · 1

    EUA # (B)(4). MEDICAL DEVICE LOT #: 0173444 WAS REPORTED, HOWEVER, THIS IS NOT A LOT# MANUFACTURED FOR THIS PRODUCT. MEDICAL 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE TESTING FOR SARS-COV-2 A FALSE NEGATIVE RESULT WAS OBTAINED. REPEAT TEST WAS PERFORMED USING A PCR TEST METHOD AND THE RESULT WAS POSITIVE. THERE WAS NO PATIENT IMPACT AS STAFF MEMBER WAS SENT HOME TO QUARANTINE WHEN SYMPTOMS DEVELOPED. EUA # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1297142 BD RAPID DETECTION OF SARS-COV-2 VERITOR¿ CORONAVIRUS ANTIGEN DETECTION SYSTEM QKP BECTON, DICKINSON & CO. (SPARKS) SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown