BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 11761635 · Received May 3, 2021

    Report

    Report Number
    1119779-2021-00760
    Event Type
    Malfunction
    Date Received
    May 3, 2021
    Date of Event
    March 16, 2021
    Report Date
    June 28, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    QJR
    UDI-DI
    00382904419165
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULT WHEN USING BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM (REF 444213) LOT K21-140 IN COMBINATION WITH THE BD MAX¿ EXK¿ TNA-3 (442827) LOTS #0302012 AND #1005832 WAS PERFORMED BY THE REVIEW OF THE MANUFACTURING RECORDS, REVIEW OF CUSTOMER¿S DATA AND VERIFICATION OF COMPLAINTS HISTORY. THE INVESTIGATION WAS CONDUCTED BY BD AND BIOGX. DATA ANALYSIS HAS REVEALED THAT SOME OF THE SAMPLES INVOLVED IN THE COMPLAINT WERE ALSO TESTED USING BD MAX¿ EXK¿ TNA3 (442827) LOT #1012579. THESE 3 KITS OF BD MAX¿ EXK¿ TNA-3 LOTS WERE THEREFORE INCLUDED IN THE INVESTIGATION. REVIEW OF THE MANUFACTURING RECORDS OF BD MAX EXK TNA-3 INDICATED THAT LOTS #0302012, #1005832 AND #1012579 WERE MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. BIOGX REVIEW OF THE QUALITY CONTROL TESTING DATA INDICATES THAT BOTH N1 (LOT 0129-21-001A) AND N2 (LOT 0148-21-001A) CONTAINED IN THE KIT LOT K21-140 PERFORM AS EXPECTED AND MEET BIOGX PERFORMANCE CRITERIA. THE CUSTOMER REPORTED DISCREPANT RESULTS (POSITIVE FOR THE N1 TARGET) FOR FIFTEEN SAMPLES AND PROVIDED FIFTEEN RUNS FILE FROM THE DATABASE INSTRUMENT CT0210. THE CUSTOMER¿S UDP SETTINGS WERE VERIFIED AND THE RESULT LOGIC PARAMETERS WERE SET IN ACCORDANCE WITH THE BIOGX SARS COV-2 INSTRUCTION FOR USE. DATA ANALYSIS SHOW THIRTEEN POSITIVE (N1 AND/OR N2) PATIENT SAMPLES, ONE NEGATIVE QC SAMPLE THAT DISPLAYED A N2 POSITIVE RESULT UPON A FIRST TEST (RUN 6734/B6) AND ONE N1/N2 POSITIVE RESULT UPON REPEAT (RUN 6736/B12). THIS SAMPLE RECEIVED A NEGATIVE RESULT USING THE BIOFIRE® ASSAY. MANUAL PCR CURVE ADJUDICATION WAS CONDUCTED ACROSS ON ALL FIFTEEN 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. PCR CURVES OF ALL SAMPLES SHOW LATE CT VALUES AND WEAK AMPLIFICATION FOR N1 AND/OR N2 TARGETS, COMBINED WITH STRONG RNASEP AMPLIFICATION, WHICH IS CHARACTERISTIC OF LOW AND TRUE POSITIVE SAMPLES. SUCH LOW POSITIVE SAMPLES CAN OCCUR DUE TO VIRAL TITERS IN THE SPECIMEN BEING AT OR NEAR THE LIMIT OF DETECTION (LOD) OF THE ASSAY OR THROUGH ENVIRONMENTAL OR CROSS CONTAMINATION INTRODUCED DURING THE SAMPLE PREPARATION AT THE CUSTOMER¿S SITE. SAMPLES AT LOD CAN HAVE VARIABLE RESULTS UPON REPEAT. MOREOVER, LIMIT OF DETECTION CAN VARY BETWEEN DIFFERENT ASSAYS. OVERALL, BD WAS UNABLE TO CONFIRM THE EXACT CAUSE OF THE CUSTOMER¿S DISCREPANT RESULTS. THERE IS NO INDICATION OF AN INCREASE IN COMPLAINTS FOR DISCREPANT RESULT FOR BIOGX SARS-COV-2 OSR LOT K21-140. THE ROOT CAUSE WAS NOT IDENTIFIED. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. BD & BIOGX PRODUCT MANUFACTURER DID NOT INITIATE A CORRECTIVE AND PREVENTIVE ACTION (CAPA).

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE TESTING FOR SARS COV-2 A FALSE POSITIVE RESULT WAS OBTAINED. A REPEAT TEST WAS PERFORMED USING THE BIOFIRE ASSAY AND THE RESULT WAS NEGATIVE. THE CUSTOMER STATED THERE WAS NO PATIENT IMPACT. EUA #: (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " IT WAS REPORTED THAT BIOGX SARS COV2 DISCREPANT RESULTS: MULTIPLE SAMPLES. CUSTOMER PROBLEM: CUSTOMER REPORTS A POSSIBLE FALSE POSITIVE RESULTS FOR N1 TARGET WITH MULTIPLE SAMPLES. WHAT DO YOU USE FOR EXTERNAL CONTROLS AND HOW DO YOU PREPARE THEM? BIOGX FOR POSITIVE CONTROL. PREPARED PER BIOGX INSTRUCTIONS. KNOWN PATIENT SAMPLE FOR NEG EXTERNAL CONTROLS. WHICH TEST IS USED FOR CONFIRMATION? 6736 A10 N1 POSITIVE N1; REPEAT RUN 6738 B2 POSITIVE N1 AND N2. BIOFIRE; NEGATIVE.  ADVERSE EFFECT ON PATIENT, IF ANY: NO. TREATMENT OR MEDICATIONS RECEIVED BY THE PATIENT, IF ANY: NO ACCESS."

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE TESTING FOR SARS COV-2 A FALSE POSITIVE RESULT WAS OBTAINED. A REPEAT TEST WAS PERFORMED USING THE BIOFIRE ASSAY AND THE RESULT WAS NEGATIVE. THE CUSTOMER STATED THERE WAS NO PATIENT IMPACT. EUA #: (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT BIOGX SARS COV2 DISCREPANT RESULTS: MULTIPLE SAMPLES. CUSTOMER PROBLEM: CUSTOMER REPORTS A POSSIBLE FALSE POSITIVE RESULTS FOR N1 TARGET WITH MULTIPLE SAMPLES. WHAT DO YOU USE FOR EXTERNAL CONTROLS AND HOW DO YOU PREPARE THEM? BIOGX FOR POSITIVE CONTROL. PREPARED PER BIOGX INSTRUCTIONS. KNOWN PATIENT SAMPLE FOR NEG EXTERNAL CONTROLS. WHICH TEST IS USED FOR CONFIRMATION? 6736 A10 N1 POSITIVE N1; REPEAT RUN 6738 B2 POSITIVE N1 AND N2. BIOFIRE; NEGATIVE.  ADVERSE EFFECT ON PATIENT, IF ANY: NO. TREATMENT OR MEDICATIONS RECEIVED BY THE PATIENT, IF ANY: NO ACCESS".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    658797 BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM SARS-COV-2 REAGENT KIT QJR BECTON, DICKINSON & CO. (SPARKS) 441916 K21-140 00382904419165

    Patients

    Seq Age Sex Outcome Treatment
    1