BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT

    MDR report key: 15580301 · Received October 11, 2022

    Report

    Report Number
    1119779-2022-01287
    Event Type
    Malfunction
    Date Received
    October 11, 2022
    Date of Event
    September 26, 2022
    Report Date
    February 6, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    OOI
    UDI-DI
    00382904419165
    PMA / PMN Number
    SEE H.10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE EXPIRATION DATE: NA. PMA/510(K)#: K111860, K130470. 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 · 0

    H.6 INVESTIGATION SUMMARY: THE COMPLAINT ALLEGES THE BD MAX INSTRUMENT (CATALOG NUMBER 441916 AND SERIAL NUMBER (B)(6)) HAD A "FALSE NEGATIVE". CUSTOMER REPORTED THAT THEY ARE HAVING DOUBTS ABOUT ASSAY RESULTS DUE TO THE PCR CURVES WHILE RUNNING THE ENTERIC VIRAL PANEL ASSAY. SERVICE AND QUALITY PERFORMED REVIEW OF THE CUSTOMER INSTRUMENT DATABASE WHICH REVEALED EVIDENCE OF READER NORMALIZER SIGNAL DRIFT AFFECTING THE ROX (585) SIGNAL. A BD FIELD SERVICE ENGINEER WAS DISPATCHED TO THE CUSTOMER SITE WHERE THEY PERFORMED READER RENORMALIZATION AND INSTALLATION OF NEW SOFTWARE SCRIPTS TO CORRECT THE ISSUE. THIS COMPLAINT IS CONFIRMED BY SERVICE & QUALITY. THE ROOT CAUSE IS DUE TO DRIFT IN NORMALIZER SIGNAL DUE TO RISE IN INTERNAL INSTRUMENT TEMPERATURE DURING PCR. AN INTERNAL CORRECTIVE AND PREVENTATIVE ACTION IS OPEN TO ADDRESS THIS ISSUE. SAMPLE ANALYSIS CONSISTED OF CUSTOMER INSTRUMENT RUN DATA FILES. ANALYSIS BY QUALITY REVEALED EVIDENCE OF READER NORMALIZER SIGNAL DRIFT AFFECTING THE ROX (585) SIGNAL. REVIEW OF DEVICE HISTORY RECORD FOR INSTRUMENT (B)(6) IS NOT REQUIRED AS THIS COMPLAINT DOES NOT ALLEGE AN EARLY LIFE FAILURE OR FAILURE AT INSTALL OF THE INSTRUMENT AND THE COMPLAINT WAS CONFIRMED THROUGH OTHER MEANS. SERVICE HISTORY REVIEW WAS PERFORMED FOR THE INSTRUMENT (B)(6), AND TWO ADDITIONAL WORK ORDERS WERE OBSERVED ON 15SEP2022 AND 26APR2022 FOR THE COMPLAINT FAILURE MODE REPORTED. BD QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS ASSOCIATED WITH THIS COMPLAINT. THERE IS AN OPEN CORRECTIVE AND PREVENTATIVE ACTION (CAPA) INVESTIGATION RELATED TO THIS COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT THERE WAS A FALSE NEGATIVE RESULT WITH THE ENTERIC VIRAL PANEL ASSAY. PATIENT SAMPLES WERE INVOLVED BUT RESULTS WERE NOT REPORTED TO THE CLINICIAN AND THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FALSE NEGATIVE RESULT ALLEGED USING BD MAX ENTERIC VIRAL PANEL ASSAY, KIT LOT 2117444. 441916 - INSTRUMENT MAX CLINICAL (B)(4). SINCE STANDARDIZATION ON THIS DEVICE IN MID-SEPTEMBER, THE CUSTOMER HAS BEEN RUNNING EVP SAMPLES DAILY ON THE BD MAX (B)(4). THE LOTTERY NUMBERS ARE 2117444 AND 2102313. THEY STILL HAD PROBLEMS WITH THE CURVES: RUN 546 - 1X FALSE NEGATIVE SAPO (IF A POSITIVE NORO) - MONSTER A8. RUN 544 - 2 CURVES WHERE THEY HAVE DOUBTS ABOUT THE SAPOVIRUS RESULTS (FLUORESCENCE WAS NOT HIGH) - SAMPLES B3 AND B5. THE LOTTERY NUMBER WAS 2117444 ON BOTH RUNS WITH PROBLEMS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT THERE WAS A FALSE NEGATIVE RESULT WITH THE ENTERIC VIRAL PANEL ASSAY. PATIENT SAMPLES WERE INVOLVED BUT RESULTS WERE NOT REPORTED TO THE CLINICIAN AND THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FALSE NEGATIVE RESULT ALLEGED USING BD MAX ENTERIC VIRAL PANEL ASSAY, KIT LOT 2117444. 441916 - INSTRUMENT MAX CLINICAL - (B)(6). SINCE STANDARDIZATION ON THIS DEVICE IN MID-SEPTEMBER, THE CUSTOMER HAS BEEN RUNNING EVP SAMPLES DAILY ON THE BD MAX (B)(6). THE LOTTERY NUMBERS ARE 2117444 AND 2102313. THEY STILL HAD PROBLEMS WITH THE CURVES: RUN 546 - 1X FALSE NEGATIVE SAPO (IF A POSITIVE NORO) - MONSTER A8. RUN 544 - 2 CURVES WHERE THEY HAVE DOUBTS ABOUT THE SAPOVIRUS RESULTS (FLUORESCENCE WAS NOT HIGH) - SAMPLES B3 AND B5. THE LOTTERY NUMBER WAS 2117444 ON BOTH RUNS WITH PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2482043 BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT INSTRUMENTATION FOR CLINICAL MULTIPLEX TEST SYSTEMS OOI BECTON, DICKINSON & CO. (SPARKS) 441916 00382904419165

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown