BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM

    MDR report key: 10002778 · Received April 27, 2020

    Report

    Report Number
    1119779-2020-00074
    Event Type
    Malfunction
    Date Received
    April 27, 2020
    Date of Event
    April 20, 2020
    Report Date
    May 7, 2020
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    QJR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY NO UPDATE PERFORMED BY BD SINCE BD DOES NOT OWN THE PRODUCT RISK MANAGEMENT FILE SINCE THE PRODUCT IS MANUFACTURED BY A PARTNER (BIOGX). NO HAZARD/ HAZARDOUS SITUATION/HARM WAS REPORTED. INVESTIGATION PERFORMED BY BIOGX, PRODUCT MANUFACTURER. THE COMPLAINT INVESTIGATION FOR FALSE POSITIVE RESULT WITH THE BIOGX SARS-COV-2 OSR ASSAY (REF #444213) LOT K20-006 WAS PERFORMED BY BIOGX, PRODUCT MANUFACTURER. THE INVESTIGATION WAS PERFORMED BY REVIEW OF THE CUSTOMER DATA AND IFU INFORMATION. THE INITIAL POSITIVE (AS REPORTED BY CUSTOMER) IN RUN 118 IS A LATE POSITIVE WITH A 37 CT FOR N1 AND A NEGATIVE RESULT FOR N2. THE SAMPLE TESTED IN RUN 119 HAS A LATE CT 35.8 FOR N1; THE CUSTOMER STATES A SECOND SAMPLE WAS TAKEN FROM THIS SAME INDIVIDUAL AND TESTED IN RUN 120 WITH RESULTS BEING NEGATIVE. BD EUA IFU INDICATES A LIMIT OF DETECTION OF 40 GE/ML YIELDING AVERAGE CT VALUES OF 33.8 AND 33.7 FOR N1 AND N2, RESPECTIVELY. BASED ON THE INFORMATION PROVIDED IN THE COMPLAINTS, WE CONCLUDE THE BIOGX REAGENTS ARE PERFORMING WITHIN SPECIFICATION. BIOGX INDICATES THAT FOR PATIENT COLLECTIONS CONTAINING VIRAL RNA LOADS BEYOND THE LOD, REPEATED PATIENT SAMPLING WOULD BE REQUIRED. END USERS MUST REFERENCE THE IFU AND UNDERSTAND LOD VALUES AND RELATIONSHIP TO VIRAL LOADS. THERE IS NO TREND FOR FALSE POSITIVE RESULT WITH THE BIOGX SARS-COV-2 OSR ASSAY LOT K20-006. BIOGX CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. THE ROOT CAUSE OF THE CUSTOMER ISSUE WAS NOT IDENTIFIED. BIOGX PRODUCT MANUFACTURER DID NOT INITIATE A PREVENTIVE AND CORRECTIVE ACTION PLAN. THE ROOT CAUSE OF THE CUSTOMER ISSUE WAS NOT IDENTIFIED. BIOGX DID NOT INITIATE A CAPA. NO CORRECTIVE AND PREVENTIVE ACTION (CAPA) WAS INITIATED AT THIS TIME BY BD SINCE BD IS NOT THE LEGAL MANUFACTURER OF THE PRODUCT AND IS ONLY THE DISTRIBUTOR FOR BIOGX AND BIOGX PRODUCT ARE NOT PART OF OUR QUALITY SYSTEM. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX¿ SYSTEM A FALSE POSITIVE RESULT WAS OBTAINED BY THE LABORATORY PERSONNEL. INITIAL RESULT WAS NOT REPORTED. NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "-CUSTOMER PROBLEM: CUSTOMER REPORTS A POTENTIAL FALSE POSITIVE RESULT FOR A PATIENT WHILE USING CAT 444213. -STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: CUSTOMER REPORTS THAT THEY HAD A PATIENT POSITIVE FOR N1 ON 4/14/2020 IN LANE A2. THE NEXT RUN, PERFORMED ON 4/20/2020, HAD ANOTHER PATIENT POSITIVE FOR N1 WHICH CUSTOMER BELIEVES IS A FALSE POSITIVE AND IT WAS IN LANE A3. THAT LAST PATIENT WAS REPEATED WITH A NEWLY COLLECTED SPECIMEN AND THE RESULT WAS NEGATIVE IN LANE A1. CUSTOMER STATES THAT, BETWEEN EACH RUN, THE BD MAX RACKS, INTERIOR OF INSTRUMENT, AND SURROUNDING COUNTERTOPS, KEYBOARDS, PIPETTES, ETC ARE CLEANED WITH 10% BLEACH FOLLOWED WITH WATER. DAILY, THE ROOM (ALL COUNTERS, CABINETS, HANDLES, KEYBOARDS, MICE, ETC¿)IS CLEANED WITH CAVI-WIPES AND/OR CHLOROX DISINFECTANT WIPES.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN DEVICE MANUFACTURE DATE: UNKNOWN A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX¿ SYSTEM A FALSE POSITIVE RESULT WAS OBTAINED BY THE LABORATORY PERSONNEL. INITIAL RESULT WAS NOT REPORTED. NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "-CUSTOMER PROBLEM: CUSTOMER REPORTS A POTENTIAL (B)(6) RESULT FOR A PATIENT WHILE USING CAT 444213. -STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: CUSTOMER REPORTS THAT THEY HAD A PATIENT (B)(6) FOR N1 ON(B)(6) 2020 IN LANE A2. THE NEXT RUN, PERFORMED ON (B)(6) 2020, HAD ANOTHER PATIENT (B)(6) FOR N1 WHICH CUSTOMER BELIEVES IS A (B)(6) AND IT WAS IN LANE A3. THAT LAST PATIENT WAS REPEATED WITH A NEWLY COLLECTED SPECIMEN AND THE RESULT WAS (B)(6) IN LANE A1. CUSTOMER STATES THAT, BETWEEN EACH RUN, THE BD MAX RACKS, INTERIOR OF INSTRUMENT, AND SURROUNDING COUNTERTOPS, KEYBOARDS, PIPETTES, ETC ARE CLEANED WITH 10% BLEACH FOLLOWED WITH WATER. DAILY, THE ROOM (ALL COUNTERS, CABINETS, HANDLES, KEYBOARDS, MICE, ETC¿)IS CLEANED WITH CAVI-WIPES AND/OR CLOROX DISINFECTANT WIPES. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467336 BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM SARS-COV-2 OSR QJR BECTON, DICKINSON & CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other