BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® LX®I 725 CLINICAL SYSTEM

    MDR report key: 2091501 · Received May 17, 2011

    Report

    Report Number
    2050012-2011-01573
    Event Type
    Malfunction
    Date Received
    May 17, 2011
    Date of Event
    April 19, 2011
    Report Date
    April 19, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K023049
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC PRIOR TO THE EVENT WAS WITHIN THE LAB'S ESTABLISHED RANGES AND QC RUN AFTER THE TREND WAS LOW. A FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT AND FOUND NO ISSUES. ALL TESTING PASSED SPECIFICATIONS. THE LABORATORY IS INVESTIGATING THE TEMPERATURE AND PROCEDURES ON THE NIGHT SHIFT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING FALSE LOW SODIUM (NA) AND POTASSIUM (K) RESULTS GENERATED BY THE SYNCHRON LX I 725 CLINICAL SYSTEM DURING THE NIGHT SHIFT. WHEN THE DAY SHIFT NOTICED THE TREND, THE SAMPLES WERE REPEATED ON THE OTHER INSTRUMENT IN THE LABORATORY AND REPORTS WERE AMENDED. THE CUSTOMER DIDN'T SUPPLY ANY ACTUAL RESULTS BUT SAID THAT THE CORRECTED NA RESULTS WERE APPROXIMATELY 10MMOL/L HIGHER THAN ORIGINALLY REPORTED. THE CORRECTED K RESULTS WERE APPROXIMATELY 0.5 TO 1.0MMOL/L HIGHER. THERE WAS NO DEATH, INJURY OR CHANGE TO PATIENT TREATMENT ATTRIBUTED TO OR CONNECTED WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1