BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SARS-COV-2 REAGENTS FOR BD MAX SYSTEM

    MDR report key: 10825807 · Received November 11, 2020

    Report

    Report Number
    1119779-2020-00990
    Event Type
    Malfunction
    Date Received
    November 11, 2020
    Date of Event
    October 19, 2020
    Report Date
    February 16, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    QJR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULT WHEN USING BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM (REF 444213) UNKNOWN LOT # WAS PERFORMED BY THE REVIEW OF THE MANUFACTURING RECORDS, REVIEW OF CUSTOMER¿S DATA AND VERIFICATION OF COMPLAINTS HISTORY. DESPITE MULTIPLE ATTEMPTS MADE TO RECEIVE INFORMATION FROM THE CUSTOMER, NO BIOGX LOT NUMBER WAS PROVIDED FOR THE INVESTIGATION. THE INVESTIGATION WAS CONDUCTED BY BD AND BIOGX SINCE DATA ANALYSIS REVEALED THAT THE KIT BIOGX SARS-COV-2 OSR WAS TESTED USING THE EXTRACTION KIT BD MAX EXK TNA-3 LOTS 0240514 & 0233797. REVIEW OF THE MANUFACTURING RECORDS OF THE BD MAX EXK TNA-3 LOTS 0240514 & 0233797 INDICATED THAT THE LOTS WERE MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. CUSTOMER REPORTED AN INCREASE OF POSITIVITY RATE AND DISCREPANT RESULTS AND PROVIDED THE DATABASE FROM INSTRUMENT CT0490 FOR INVESTIGATION. THE CUSTOMER¿S UDP SETTINGS WERE VERIFIED 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, CUSTOMER OBTAINED SPECIMENS WITH DISCREPANT RESULTS, WHICH WERE N1 POSITIVE, BUT NEGATIVE UPON REPEAT. ANALYSIS OF THE DATABASE SHOWS AN INCREASE OF N1 POSITIVE RESULTS DURING THE TIME PERIOD MENTIONED BY THE CUSTOMER COMPARED TO WHAT WAS OBTAINED BEFORE THAT PERIOD. NO INFORMATION WAS PROVIDED TO IDENTIFY SPECIFIC SAMPLES CONCERNED, BUT DETAILS IN THE COMPLAINT TEXT ALLOWED TO FIND NINE SAMPLES CORRESPONDING TO THE DESCRIPTION (N1 POSITIVE ONLY, ONE WEEK BEFORE OCTOBER 26TH). MANUAL PCR CURVE ADJUDICATION WAS CONDUCTED ACROSS THESE NINE SAMPLES. MANUAL CURVE ADJUDICATION HAS LIMITATIONS; VISUAL EXAMINATION OF PCR CURVES FOR LOW SIGNAL AND/OR ABERRANT CURVE GEOMETRY IS AN EXTREMELY CONSERVATIVE ASSESSMENT OF THE DATA. ANALYSIS OF THE PCR CURVE SHOWS A TRUE BUT LATE AMPLIFICATION WITHOUT ANOMALY. MOREOVER, SOME VERY STRONG POSITIVE RESULTS (N1/N2 POSITIVE) WERE TESTED DURING THE SAME PERIOD. LOW POSITIVE SAMPLES CAN OCCUR DUE TO ENVIRONMENTAL OR CROSS CONTAMINATION INTRODUCED DURING THE SAMPLE PREPARATION AT THE CUSTOMER¿S SITE OR VIRAL TITERS IN THE SPECIMEN BEING AT OR NEAR THE ASSAY LIMIT OF DETECTION (LOD). HOWEVER, BD IS UNABLE TO CONFIRM THIS HYPOTHESIS. THERE IS NO INDICATION OF AN INCREASE IN COMPLAINTS FOR DISCREPANT RESULT FOR BIOGX SARS-COV-2 OSR LOT PRODUCT. THE ROOT CAUSE WAS NOT IDENTIFIED BUT CONTAMINATION BY CUSTOMERS AND/OR TRUE POSITIVE SAMPLE AT THE LIMIT OF DETECTION ARE SUSPECTED. 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 THERE WAS AN INCREASED POSITIVITY RATE. UPON REPEAT THE SAMPLES WERE NEGATIVE. THE CUSTOMER STATED THERE WAS NO IMPACT TO PATIENTS AS SAMPLES ARE REPEATED PRIOR TO THE RELEASE OF RESULTS. EUA #: (B)(4).

    Additional Manufacturer Narrative · 1

    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 THERE WAS AN INCREASED POSITIVITY RATE. UPON REPEAT THE SAMPLES WERE NEGATIVE. THE CUSTOMER STATED THERE WAS NO IMPACT TO PATIENTS AS SAMPLES ARE REPEATED PRIOR TO THE RELEASE OF RESULTS. EUA #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1291886 BD SARS-COV-2 REAGENTS FOR BD MAX SYSTEM SARS-COV-2 REAGENT KIT QJR BECTON, DICKINSON & CO. (SPARKS) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1