BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 10278537 · Received July 15, 2020

    Report

    Report Number
    1119779-2020-00219
    Event Type
    Malfunction
    Date Received
    July 15, 2020
    Date of Event
    June 25, 2020
    Report Date
    September 17, 2020
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    QJR
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    EUA: (B)(4). INVESTIGATION SUMMARY: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULT USING THE BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM (REF: (B)(4), LOT K20-120 WAS PERFORMED BY BD. THE INVESTIGATION WAS PERFORMED BY THE REVIEW OF THE INFORMATION PROVIDED BY THE CUSTOMER AND VERIFICATION OF COMPLAINTS HISTORY. THIS COMPLAINT CONCERNED A DISCREPANT RESULT. HOWEVER, THE SAMPLE WAS NOT IDENTIFIED BY THE CUSTOMER. ALTHOUGH THE DATABASE WAS AVAILABLE, IT WAS NOT POSSIBLE TO FIND THE DISCREPANT RESULTS. THE COMPLAINT TEXT MENTIONED THAT ONE PATIENT WAS NEGATIVE WITH A JAGGED CURVE AND WAS REPEATED ONE WEEK LATER FROM ANOTHER COLLECTION, AND THE RESULT WAS POSITIVE. A THIRD RUN FROM THE SAME PATIENT GAVE A NEGATIVE RESULT AGAIN. PREVIOUS CUSTOMER COMPLAINT INDICATED THAT THERE IS AN OBVIOUS MUXBOARD ISSUE WITH THE DECK A OF THIS INSTRUMENT AND REVIEW OF THESE COMPLAINTS REVEALED A CARTRIDGE DRAWER POSSIBLY TILTED, THE DISCREPANT RESULT MAY HAVE BEEN CAUSED BY THIS ISSUE. THERE IS ALSO THE POSSIBILITY THAT THE PATIENT TESTED ON 3 OCCASIONS PROVIDED SAMPLES AT THE LIMIT OF DETECTION (LOD) OF THE ASSAY, WHICH WOULD EXPLAIN THE DISCREPANCIES BETWEEN SPECIMEN COLLECTIONS. SAMPLE CONTAMINATION COULD ALSO EXPLAIN THE DISCREPANCIES BETWEEN SPECIMEN COLLECTIONS RESULTS. COMPLAINTS HISTORY SHOWED NO OTHER COMPLAINTS FOR DISCREPANT RESULTS ON THE BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM PRODUCT LOT: K20-120. THE ROOT CAUSE WAS NOT FOUND. BD RECOMMEND TO HAVE A BD FIELD SERVICE ENGINEER VERIFY FOR PROPER BD MAX ALIGNMENT AND OPERATION. THE BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM PRODUCT ARE NOT SUSPECTED TO BE IN CAUSE. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. NO CORRECTIVE AND PREVENTIVE ACTION (CAPA) WAS INITIATED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX¿ SYSTEM DISCREPANT RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. THE FIRST RUN WAS NEGATIVE DUE TO A JAGGED CURVE. THE CUSTOMER REPEATED THE TEST WITH A RE-COLLECTED SAMPLE AND THE RESULT WAS POSITIVE. THE CUSTOMER INTERPRETED THOSE RESULTS AS A FALSE POSITIVE AND REPEATED THE SAMPLE. THE REPEAT RESULT WAS NEGATIVE. THE NEGATIVE RESULT WAS REPORTED TO THE CLINICIAN AND THERE WAS NO REPORT OF PATIENT IMPACT OR CHANGE IN COURSE OF TREATMENT.

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING THE BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX¿ SYSTEM DISCREPANT RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. THE FIRST RUN WAS NEGATIVE DUE TO A JAGGED CURVE. THE CUSTOMER REPEATED THE TEST WITH A RE-COLLECTED SAMPLE AND THE RESULT WAS POSITIVE. THE CUSTOMER INTERPRETED THOSE RESULTS AS A FALSE POSITIVE AND REPEATED THE SAMPLE. THE REPEAT RESULT WAS NEGATIVE. THE NEGATIVE RESULT WAS REPORTED TO THE CLINICIAN AND THERE WAS NO REPORT OF PATIENT IMPACT OR CHANGE IN COURSE OF TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745090 BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM SARS-COV-2 REAGENT KIT QJR BECTON, DICKINSON & CO. K20-120

    Patients

    Seq Age Sex Outcome Treatment
    1 Other