BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNCHRON LX I 725 CLINICAL SYSTEM

    MDR report key: 1182446 · Received September 12, 2008

    Report

    Report Number
    2122870-2008-00274
    Event Type
    Other
    Date Received
    September 12, 2008
    Date of Event
    August 19, 2008
    Report Date
    September 12, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K023049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS DRAWN INTO A BD LITHIUM HEPARIN PLASMA TUBE WITH GEL AND WAS CENTRIFUGED AT 3,500 RPM FOR 5 MINUTES UTILIZING A SWINGING BUCKET ROTOR. PER TUBE MANUFACTURER'S INSERT, THE RECOMMENDED CENTRIFUGATION TIME FOR THE TUBE IN USE IS 10 MINUTES. IN 2008, THE CUSTOMER REPORTED TO CUSTOMER TECHNICAL SUPPORT (CTS) THAT AN ANT WAS OBSERVED INSIDE THE SAMPLE TUBE AFTER THEY REMOVED IT FROM THE INSTRUMENT. THE CUSTOMER INFORMED THEY HAVE BEEN HAVING AN INFESTATION OF ANTS IN THE LABORATORY. IT IS NOT KNOWN AT WHAT TIME THE ANT ENTERED THE SAMPLE NOR IS IT KNOWN WHAT EFFECT IT MAY HAVE HAD ON THE RESULTS. TWO DAYS PRIOR, A SYSTEM CHECK WAS COMPLETED AND MET SPECIFICATIONS. THE NEXT DAY, TWO LEVELS OF QC WERE TESTED PRIOR TO THE EVENT AND RESULTED WITHIN THE ESTABLISHED RANGE. FOLLOWING THE EVENT, SOME QC ISSUES WERE OBSERVED. A FIELD SERVICE ENGINEER (FSE) WAS ONSITE ON ORIGINAL DATE: FSE PERFORMED ALIGNMENTS AND CHECKED/ADJUSTED ULTRASONICS. A SYSTEM CHECK AND QC WERE COMPLETED. NO ISSUES WERE NOTED BY THE FSE. FSE VERIFIED REPAIR PER ESTABLISHED PROCEDURES AND RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS. A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING AN ERRONEOUSLY ELEVATED ACCU TNI RESULT, GENERATED BY THE SYNCHRON LX I 725 CLINICAL SYSTEM FOR ONE PATIENT. CUSTOMER TESTED A SAMPLE FOR ACCU TNI AND OBTAINED A RESULT OF 0.95NG/ML. UPON REPEAT, IT GAVE A RESULT OF 0.03NG/ML AND WHEN REPEATED ON A DIFFERENT INSTRUMENT A RESULT OF 0.02NG/ML WAS OBTAINED. ANOTHER SAMPLE OBTAINED FROM THIS PATIENT WHEN TESTED GAVE A RESULT OF 0.02NG/ML. THE ERRONEOUS RESULT WAS REPORTED OUTSIDE THE LABORATORY. THE PATIENT WAS PLACED ON ANTI-COAGULANTS AND ADMITTED. TO DATE, NO REPORT OF INJURY OR DEATH HAS BEEN RECEIVED IN CONJUNCTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON LX I 725 CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER MMI BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA