BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM

    MDR report key: 10962231 · Received December 7, 2020

    Report

    Report Number
    1119779-2020-01173
    Event Type
    Malfunction
    Date Received
    December 7, 2020
    Date of Event
    November 20, 2020
    Report Date
    February 18, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    QJR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULT WHEN USING BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM (REF 444213) LOT K20-504 WAS PERFORMED BY THE REVIEW OF THE MANUFACTURING RECORDS AND VERIFICATION OF COMPLAINTS HISTORY. THE INVESTIGATION WAS CONDUCTED BY BD AND BIOGX SINCE DATA ANALYSIS HAS REVEALED THAT THE BIOGX SARS-COV-2 OSR KIT WAS TESTED ALONG WITH BD MAX EXK TNA-3 LOT 0259558. REVIEW OF THE MANUFACTURING RECORDS OF BD MAX EXK TNA-3 LOT 0259558 INDICATED THAT LOT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. BIOGX REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT K20-504 LOT SHOWS ACCEPTABLE PERFORMANCE CHARACTERISTICS. THE CUSTOMER REPORTED FALSE POSITIVE RESULTS ON THE SAMPLES PERFORMED ON CT0418 IN RUN 8268. THIS RUN DID NOT CONTAIN ANY CONTROL. NEW PATIENT SAMPLES, AS WELL AS CONTROLS, WERE PERFORMED IN THE SUBSEQUENT RUN AND BASED ON WHAT THE CUSTOMER HAS REPORTED, NO POSITIVE RESULT WAS OBTAINED. THE UDP SETTINGS WERE VERIFIED BY THE CUSTOMER AND THE RESULT LOGIC PARAMETERS WERE SET IN ACCORDANCE WITH THE BIOGX SARS COV-2 PACKAGE INSERT INSTRUCTION FOR USE. ACCORDING TO THE COMPLAINT TEXT, THE CUSTOMER WAS SUPPOSED TO REPEAT THE SAMPLES, BUT NO ADDITIONAL INFORMATION WAS RECEIVED SINCE, EVEN THOUGH THE CUSTOMER WAS CONTACTED MULTIPLE TIMES. MOREOVER, NO DATA WAS PROVIDED FOR THE INVESTIGATION. THEREFORE, BD WAS UNABLE TO FURTHER INVESTIGATE THE ISSUE. THERE IS NO INDICATION OF AN INCREASE IN COMPLAINTS FOR DISCREPANT RESULT FOR BIOGX SARS-COV-2 OSR LOT K20-504. THE ROOT CAUSE WAS NOT IDENTIFIED. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING FOR SARS-COV-2 FALSE POSITIVE RESULTS WERE OBTAINED. CUSTOMER REPORTED CONFIRMATORY TESTING WOULD BE PERFORMED, HOWEVER, WHAT TYPE AND RESULTS HAVE NOT BEEN REPORTED. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION, HOWEVER, THE CUSTOMER HAS NOT RESPONDED. (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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE TESTING FOR SARS-COV-2 FALSE POSITIVE RESULTS WERE OBTAINED. CUSTOMER REPORTED CONFIRMATORY TESTING WOULD BE PERFORMED, HOWEVER, WHAT TYPE AND RESULTS HAVE NOT BEEN REPORTED. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION, HOWEVER, THE CUSTOMER HAS NOT RESPONDED. EUA# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1426987 BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM SARS-COV-2 REAGENT KIT QJR BECTON, DICKINSON & CO. (SPARKS) K20-504

    Patients

    Seq Age Sex Outcome Treatment
    1