BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROPROBE¿ PROCESSOR (120 V)

    MDR report key: 15811208 · Received November 16, 2022

    Report

    Report Number
    1119779-2022-01394
    Event Type
    Malfunction
    Date Received
    November 16, 2022
    Date of Event
    October 28, 2022
    Report Date
    February 27, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JQW
    UDI-DI
    00382902501008
    PMA / PMN Number
    K923268
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY THE COMPLAINT ALLEGES THE AFFIRM INSTRUMENT (CATALOG NUMBER 250100 AND SERIAL NUMBER (B)(6) ) HAD A "FALSE POSITIVE". CUSTOMER REPORTED THAT THEY RECEIVED ALL SUSPECTED FALSE POSITIVE RESULTS ON A SINGLE RUN. CUSTOMER ALSO REPORTED THAT THEY NOTICED THE CARDS DID NOT FLIP ALL THE WAY UP AT THE END OF THE RUN. BD SERVICE SPECIALISTS FOLLOWED-UP WITH THE CUSTOMER WHO CONFIRMS THAT THE ISSUE OCCURRED WITH ONE RUN ONLY AND THE ISSUE WAS AN ISOLATED EVENT. THE CUSTOMER HAS PERFORMED ADDITIONAL RUNS SINCE THE ONE OCCURRENCE, USING THE SAME AFFIRM KIT AND PROCESSOR, AND TESTING HAS BEEN SATISFACTORY WITH NO RECURRENCE OF THE ISSUE. THIS COMPLAINT IS UNCONFIRMED AS IT ALLUDES TO A CONTAMINATION ISSUE. THE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. NO SAMPLES WERE EXPECTED TO BE RECEIVED AS PART OF THIS COMPLAINT, AND THEREFORE NO SAMPLES WERE RETURNED, AND NO RETURNED MATERIAL INVESTIGATION COULD OCCUR. REVIEW OF DEVICE HISTORY RECORD FOR INSTRUMENT SERIAL NUMBER, A570031 IS NOT REQUIRED AS THE ISSUE WAS NOT RELATED TO THE INSTRUMENT AND DOES NOT ALLUDE A MANUFACTURING ERROR. SERVICE HISTORY REVIEW WAS NOT PERFORMED FOR THE INSTRUMENT AS THIS INSTRUMENT DOES NOT RECEIVE ANY SERVICE. BD QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS ASSOCIATED WITH THIS COMPLAINT. NO NEW RISKS OR HAZARDS, OR CHANGES TO EXISTING RISKS/HAZARDS, WERE IDENTIFIED AS A RESULT OF THIS COMPLAINT. H3 OTHER TEXT : SEE H.10.

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD MICROPROBE¿ PROCESSOR (120 V) THAT THERE WAS FALSE POSITIVES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MICROPROBE - 250100 - ALL POSITIVE RESULTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD MICROPROBE¿ PROCESSOR (120 V) THAT THERE WAS FALSE POSITIVES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MICROPROBE - 250100 - ALL POSITIVE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1861050 BD MICROPROBE¿ PROCESSOR (120 V) STATION PIPETTING AND DILUTING, FOR CLINICAL USE JQW BECTON, DICKINSON & CO. (SPARKS) 250100 00382902501008

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown