BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® LX® I 725 CLINICAL SYSTEM

    MDR report key: 1832483 · Received September 13, 2010

    Report

    Report Number
    2050012-2010-00739
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    August 24, 2010
    Report Date
    September 10, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K023049
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    PRIOR TO THIS EVENT, THE NA, K, AND CA QC RESULTS WERE WITHIN THE LAB'S ESTABLISHED RANGES. THE CUSTOMER CONTACTED THE BCI HOTLINE AND TROUBLESHOOT (TS) THE SYSTEM. THE ISSUE WAS RESOLVED WHEN FRESH CALIBRATORS WERE OPENED AND USED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING ERRONEOUSLY LOW SODIUM (NA), POTASSIUM (K), AND CALCIUM (CA) RESULTS FOR MULTIPLE PATIENT SPECIMENS GENERATED BY THE SYNCHRON LX I 725 CLINICAL SYSTEM. ERRONEOUS RESULTS WERE REPORTED OUTSIDE THE LABORATORY. SAMPLES WERE REDRAWN AND THE RESULTS WERE AMENDED AND REPORTED OUT. CUSTOMER INDICATED THAT NO PATIENTS WERE TREATED BASED ON THE ERRONEOUSLY LOW RESULTS.

    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. LX® I 725 NA

    Patients

    Seq Age Sex Outcome Treatment
    1