BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNCHRON LX20 PRO

    MDR report key: 1120644 · Received August 14, 2008

    Report

    Report Number
    2050012-2008-00036
    Event Type
    Other
    Date Received
    August 14, 2008
    Date of Event
    July 18, 2008
    Report Date
    August 14, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K011213
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    SUCCESSFUL CALIBRATION WAS PERFORMED EARLIER ON THE DAY OF THE EVENT. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED: FSE REPLACED MULTIPLE PARTS: MODULAR CHEMISTRY (MC) PROBE, LEVEL SENSE BEAD, THREE WAY VALVE, MC CRANE TUBING, OBSTRUCTION DETECTOR AND MC SAMPLE SYRINGE. FSE ALSO PERFORMED ALL MC CRANE ALIGNMENTS. IN A FOLLOW UP CALL IN 2008: CUSTOMER STATED THAT THE INSTRUMENT HAS BEEN RUNNING FINE WITH NO OTHER FLYERS SEEN. 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 LOW PHOSPHOROUS (PHOSM) TEST RESULT PRODUCED BY THE SYNCHRON LX20 PRO CLINICAL CHEMISTRY ANALYZER. ONE PATIENT WITH A FALSELY LOW PHOSM OF 0.6 MG/DL TRIGGERED THE CRITICAL RERUN FEATURE ON THE INSTRUMENT. UPON RERUN, A PHOSM RESULT OF 3.6 MG/DL WAS OBTAINED. ERRONEOUS RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NOT EFFECT TO PATIENT OR USER WITH REGARDS TO THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA