BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT

    MDR report key: 15452468 · Received September 19, 2022

    Report

    Report Number
    1119779-2022-01210
    Event Type
    Malfunction
    Date Received
    September 19, 2022
    Date of Event
    September 10, 2022
    Report Date
    November 30, 2022
    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
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: THE COMPLAINT ALLEGES THE BD MAX INSTRUMENT (CATALOG NUMBER 441916 AND SERIAL NUMBER (B)(6)) HAD "FALSE POSITIVES" WHILE RUNNING THE STAPH SR ASSAY. FSE WAS DISPATCHED TO THE CUSTOMER SITE. DURING HEALTH CHECK, SERVICE FOUND THAT THE SIDE A READER SHOWED NORM RATIO NUMBERS SEVERELY OUTSIDE OF SPECIFICATION FOR LEDS 4 & 5. FSE REMOVED READERS AND FOUND THE APERTURE PLATE ON SIDE A TO BE EXTREMELY DIRTY. SERVICE CLEANED AND RE-INSTALLED BOTH READERS. RAN READER NORMALIZATION FOR SIDE A, AND ALL LEDS WERE WELL WITHIN SPEC AFTERWARD. RAN A FULL 5CH 24-SAMPLE QUALIFICATION, WHICH PASSED WITH NO ISSUES. INSTRUMENT RETURNED TO THE CUSTOMER OPERATING TO BD SPECIFICATIONS. THIS COMPLAINT IS CONFIRMED BY SERVICE. THE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. SAMPLES WERE NOT RECEIVED BY QUALITY FOR INVESTIGATION AND THUS, RETURNED MATERIAL INVESTIGATION COULD NOT OCCUR. IF SAMPLES ARE RECEIVED AT A LATER DATE, THE COMPLAINT MAY BE REOPENED. REVIEW OF DEVICE HISTORY RECORD FOR INSTRUMENT (B)(6) IS NOT REQUIRED AS THIS COMPLAINT DOES NOT ALLEGE AN ELF/FAI OF THE INSTRUMENT AND THE COMPLAINT WAS CONFIRMED THROUGH OTHER MEANS. SERVICE HISTORY REVIEW WAS PERFORMED FOR THE INSTRUMENT (B)(6), AND NO ADDITIONAL WORK ORDERS WERE OBSERVED FOR THE COMPLAINT FAILURE MODE REPORTED. COMPLAINTS FOR RESULTS ARE WITHIN STATISTICAL CONTROL FOR THE MONTH OF SEPTEMBER 2022. THE UPPER CONTROL LIMIT WAS NOT BREACHED, AND TRENDS WERE NOT IDENTIFIED ASSOCIATED WITH THIS DEFECT. NO NEW RISKS OR HAZARDS, OR CHANGES TO EXISTING RISKS/HAZARDS, WERE IDENTIFIED AS A RESULT OF THIS COMPLAINT. PER BALTRM-MAXINST-APH REV 22 THE POTENTIAL RISK OF THE REPORTED FAILURE MODE IS FALSE POSITIVE, WHICH IS AN S3; REFERENCE (B)(4).

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT THE CUSTOMER NOTICED A POSSIBLE ISSUE WITH THE STAPH SR ASSAY WITH AN UNUSUALLY HIGH NUMBER OF POSITIVES. WHEN REPEATING THE TEST, THE RESULTS WEREN'T POSITIVE FOR ALL, MAYBE JUST ONE WAS POSITIVE BUT EVEN THAT RESULT WAS QUESTIONED BECAUSE THE CURVE DIDN'T LOOK CONVINCING. THE CUSTOMER SUSPECTS 13 SAMPLES HAVE FALSE POSITIVE RESULTS. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER IS REPORTING POSSIBLE ISSUE WITH THEIR STAPH SR ASSAY. THEY RUN THE ASSAY AND NOTICE AN UNUSUALLY HIGH NUMBER OF POSITIVE. WHEN THEY REPEAT THE TEST, IT DIDN¿T TURN POSITIVE FOR ALL, MAYBE ONLY 1 TURNED POSITIVE. BUT, WHEN SHE LOOKED AT THE CURVE, IT IS JUST DOESN¿T LOOK CONVINCING THAT IT IS A TRUE POSITIVE. SHE GETS AROUND 13 POSITIVES ON THIS INSTRUMENT FOR THE 1ST RUN. THIS IS A RELATIVELY NEWER INSTRUMENT, AND SHE ONLY RAN STAPH SR AND GBS ASSAY. SHE DIDN¿T HAVE THIS KIND OF ISSUE WITH GBS ASSAY. SHE IS A BIT CONCERN ABOUT THE RESULTS. LOT# IS 2110909. CUSTOMER SUSPECTS 13 SAMPLES HAVE FALSE POSITIVES BECAUSE THE CURVE DOESN'T LOOK CONVINCING THAT IT IS TRUE POSITIVE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT THE CUSTOMER NOTICED A POSSIBLE ISSUE WITH THE STAPH SR ASSAY WITH AN UNUSUALLY HIGH NUMBER OF POSITIVES. WHEN REPEATING THE TEST, THE RESULTS WEREN'T POSITIVE FOR ALL, MAYBE JUST ONE WAS POSITIVE BUT EVEN THAT RESULT WAS QUESTIONED BECAUSE THE CURVE DIDN'T LOOK CONVINCING. THE CUSTOMER SUSPECTS 13 SAMPLES HAVE FALSE POSITIVE RESULTS. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER IS REPORTING POSSIBLE ISSUE WITH THEIR STAPH SR ASSAY. THEY RUN THE ASSAY AND NOTICE AN UNUSUALLY HIGH NUMBER OF POSITIVE. WHEN THEY REPEAT THE TEST, IT DIDN¿T TURN POSITIVE FOR ALL, MAYBE ONLY 1 TURNED POSITIVE. BUT, WHEN SHE LOOKED AT THE CURVE, IT IS JUST DOESN¿T LOOK CONVINCING THAT IT IS A TRUE POSITIVE. SHE GETS AROUND 13 POSITIVES ON THIS INSTRUMENT FOR THE 1ST RUN. THIS IS A RELATIVELY NEWER INSTRUMENT, AND SHE ONLY RAN STAPH SR AND GBS ASSAY. SHE DIDN¿T HAVE THIS KIND OF ISSUE WITH GBS ASSAY. SHE IS A BIT CONCERN ABOUT THE RESULTS. LOT# IS 2110909. CUSTOMER SUSPECTS 13 SAMPLES HAVE FALSE POSITIVES BECAUSE THE CURVE DOESN'T LOOK CONVINCING THAT IT IS TRUE POSITIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2739788 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