BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAX SYSTEM, BD MAX INSTRUMENT

    MDR report key: 10488075 · Received September 3, 2020

    Report

    Report Number
    1119779-2020-00308
    Event Type
    Malfunction
    Date Received
    September 3, 2020
    Date of Event
    August 27, 2020
    Report Date
    March 1, 2021
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    OOI
    UDI-DI
    00382904419165
    PMA / PMN Number
    K111860
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY THE COMPLAINT OF FALSE POSITIVE RESULTS WITH BIOGX SARA COV 2 WAS REPORTED AGAINST THE MAX INSTRUMENT CATALOG NUMBER 441916, SERIAL NUMBER (B)(6). BIOGX REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT K20-306 LOT SHOWS ACCEPTABLE PERFORMANCE CHARACTERISTICS. CUSTOMER PROVIDED 2 RUNS AND REPORTED A FALSE POSITIVE N2 IN RUN #874, LANE B8 AND A NEGATIVE RESULT IN RUN #881, LANE A1. ANALYSIS OF THE CURVES FROM FIRST SAMPLE RUN #874, LANE B8 SHOW AN IRREGULAR CURVE WITH A SIGNAL INCREASE AT THE SAME CT VALUE IN BOTH CHANNELS. HOWEVER, THE SIGNAL INCREASE IN THE N2 PCR CURVE CAUSED AN INTERRUPTION OF BACKGROUND CORRECTION GENERATING A STEADY INCREASE OF FLUORESCENCE RESULTING IN A FALSE POSITIVE RESULT. THERE ARE VARIOUS POTENTIAL CONTRIBUTORS THAT COULD LEAD TO THIS TYPE OF CURVE ALL OF WHICH ATTRIBUTED TO A SAMPLE PROCESSING ERROR OF UNKNOWN ORIGIN. ONE OF THE POTENTIAL CONTRIBUTORS COULD BE BUBBLES IN THE CARTRIDGE WELL COMING FROM VARIOUS ELEMENTS (TIPS, INSTRUMENT, WORKFLOW, ETC.). ANALYSIS OF THE CURVES FOR THE SECOND SAMPLE, RUN #881, LANE A1 SHOW NO AMPLIFICATION FURTHER SUPPORTING THE PROBABLE NEGATIVE STATUS OF THE SAMPLE. BASED ON COMPLAINTS REVIEW FOR THE BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM LOT K20-306, THERE IS NO INDICATION OF AN INCREASE IN COMPLAINTS FOR FALSE POSITIVE COMPLAINTS FOR THIS LOT. THE ROOT CAUSE WAS NOT IDENTIFIED. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. THE INVESTIGATION CONSISTED OF A REVIEW OF THE CUSTOMER COMPLAINT AND SERVICE NOTES, THE COMPLAINT HISTORY FOR THE INSTRUMENT, AND RELATED CUSTOMER COMPLAINT DATA. NO PARTS OR MATERIALS WERE RETURNED AS A PART OF THIS COMPLAINT INVESTIGATION. NO NEW RISKS, TRENDS, OR HAZARDS WERE IDENTIFIED BASED ON THIS INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT A FALSE POSITIVE RESULT WAS OBTAINED BY THE LABORATORY PERSONNEL.THE TEST WAS REPEATED AND UPON REPEAT THE RESULT WAS NEGATIVE. ERRONEOUS RESULTS WERE NOT REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: NA. THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL DEVICE TYPE IS AS FOLLOWS: PMA / 510(K)#: K130470. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT A FALSE POSITIVE RESULT WAS OBTAINED BY THE LABORATORY PERSONNEL. THE TEST WAS REPEATED AND UPON REPEAT THE RESULT WAS NEGATIVE. ERRONEOUS RESULTS WERE NOT REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    951001 BD MAX SYSTEM, BD MAX INSTRUMENT INSTRUMENT FOR CLINICAL MULTIPLEX TEST SYSTEMS OOI BECTON, DICKINSON & CO. 441916 NA 00382904419165

    Patients

    Seq Age Sex Outcome Treatment
    1 Other