BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 10554092 · Received September 18, 2020

    Report

    Report Number
    1119779-2020-00347
    Event Type
    Malfunction
    Date Received
    September 18, 2020
    Date of Event
    September 2, 2020
    Report Date
    November 18, 2020
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    QJR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULTS USING THE BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM (REF (B)(4)) (UNKNOWN LOT #) ALONG WITH THE KIT BD MAX EXK TNA 3 PRODUCT LOT 0182268 WAS PERFORMED BY BD. SINCE NO KIT LOT # WAS PROVIDED BY THE CUSTOMER, BIOGX COULD NOT PERFORM THE MANUFACTURING REVIEW ON THE BIOGX SARS-COV-2 OSR SPECIFIC LOT. THE INVESTIGATION WAS PERFORMED BY THE REVIEW OF MANUFACTURING RECORD ON THE BD MAX EXK TNA 3 KIT LOT 0182268, THE REVIEW OF CUSTOMER DATA AND THE VERIFICATION OF COMPLAINTS HISTORY. REVIEW OF THE MANUFACTURING RECORDS OF THE BD MAX EXK TNA 3 INDICATED THAT THE LOT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS. CUSTOMER REPORTED HIGH POSITIVE RESULTS AND PROVIDED DATABASE FROM INSTRUMENT CT1735 FOR ANALYSIS. THE RUN #104 NAMED IN THE COMPLAINT TEXT CONTAINED MOSTLY POSITIVE RESULTS, BUT CUSTOMER DID NOT MENTION WHICH SAMPLE WAS DISCREPANT. ANALYSIS OF THE DATABASE SHOWS THAT SOME ENVIRONMENTAL MONITORING WAS DONE AND MANY OF THE SITES TESTED WERE POSITIVE. THE RUN #116 SHOWS THAT ALL SURFACE SWABBED GAVE POSITIVE RESULTS, SOMETIMES ONLY FOR N1 AND OTHER TIMES FOR BOTH N1 AND N2. ANALYSIS OF THE CURVES REVELATED HIGH FLUORESCENCE VALUES OF EACH SAMPLE AND TRUE AMPLIFICATION. MOREOVER, AN ENVIRONMENTAL SAMPLE TAKEN ON QIAQUANT COUNTERTOP OBTAINED CT VALUES AROUND 22 FOR BOTH TARGETS, WHICH REPRESENTS A HIGH LOAD. AN ENVIRONMENTAL CONTAMINATION IS STRONGLY SUSPECTED, AND THE QIAQUANT COUNTER TOP COULD BE THE SOURCE. THERE IS NO INDICATION OF AN INCREASE IN COMPLAINTS FOR DISCREPANT RESULTS COMPLAINTS FOR THE BIOGX SARS-COV-2 OSR PRODUCT. THE ROOT CAUSE WAS NOT IDENTIFIED. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. BD & BIOGX PRODUCT MANUFACTURERS DID NOT INITIATE A CORRECTIVE AND PREVENTIVE ACTION (CAPA). EUA #: EUA (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX¿ SYSTEM A HIGH LEVEL OF FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. EUA #: EUA (B)(4).

    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. (B)(4). EUA #: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX¿ SYSTEM A HIGH LEVEL OF FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. EUA #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1021925 BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM SARS-COV-2 REAGENT KIT QJR BECTON, DICKINSON & CO. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other