BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® LX20 PRO ANALYZER

    MDR report key: 2800690 · Received October 22, 2012

    Report

    Report Number
    2050012-2012-01757
    Event Type
    Malfunction
    Date Received
    October 22, 2012
    Date of Event
    September 10, 2012
    Report Date
    September 26, 2012
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K011213
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BEC HOTLINE HAD THE CUSTOMER PERFORM CUVETTE WASHING PROCEDURE ON (B)(6) 2012 AS NEEDED PER MAINTENANCE PROCEDURE, BUT THIS DID NOT RESOLVE THE ISSUE. QC RESULTS WERE ORIGINALLY WITHIN ACCEPTABLE LIMITS BETWEEN THE TIME FRAME OF (B)(6) 2012 BUT BY THE TIME THE CUSTOMER CALLED AND REQUESTED FIELD SERVICE ON (B)(6) 2012, THE QC WAS OUT OF ACCEPTABLE LIMITS. NO OTHER ANALYTES WERE IN QUESTION BY THE CUSTOMER. NO OTHER PATIENT POPULATION OR SAMPLES WERE IN QUESTION. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(6) 2012. FSE REPLACED THE CARTRIDGE CHEMISTRY (CC) SAMPLE AND REAGENT PROBES, MIXER PADDLES, MIXER WASH STATION INSERTS, CC SAMPLE WASH COLLAR AND CC SAMPLE SYRINGE. THE CAUSE OF THIS EVENT IS ATTRIBUTED TO THE CC INSTRUMENT SIDE HARDWARE. PATIENT INFORMATION HAS BEEN COMPLETED USING INFORMATION FOR PATIENT 1 INVOLVED IN THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER SCREENED FIFTY-FIVE (55) HOSPITAL PERSONNEL FOR HBA1C2 OVER A FEW DAYS STARTING (B)(6) 2012. THE CUSTOMER INFORMED BECKMAN COULTER INC. (BEC) THAT THEY FELT TOO MANY PATIENT RESULTS WERE FALSELY ELEVATED ABOVE THEIR REFERENCE INTERVAL OF >6.2% WHICH DID NOT MATCH THEIR PREVIOUS EMPLOYEE SCREENS. OF THE 55 EMPLOYEES SCREENED, THE LABORATORY DETERMINED 17 WERE CONSIDERED FALSELY HIGH. WITH DATA PROVIDED BY THE CUSTOMER, BEC INVESTIGATOR ONLY FOUND 16 ERRONEOUSLY HIGH. OF THE 16, THE CUSTOMER NOTED THAT THE ORIGINAL HIGH RESULTS ON 2 PATIENTS WERE ACCEPTABLE AND NOT CONSIDERED ERRONEOUS. NO RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. FINAL REPORTED RERUNS WERE PERFORMED AFTER FIELD SERVICE ENGINEER REPAIRED THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON® LX20 PRO ANALYZER CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. LX 20 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1