BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEMS

    MDR report key: 1170275 · Received September 11, 2008

    Report

    Report Number
    2050012-2008-00052
    Event Type
    Malfunction
    Date Received
    September 11, 2008
    Date of Event
    August 20, 2008
    Report Date
    September 11, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    QC WAS RUN ON THE DAY OF THE EVENT AND RESULTS WERE WITHIN THE LAB'S ESTABLISHED RANGES. LATER IN THE DAY, THE LAB WAS NOTIFIED THAT K RESULTS WERE LOW. QC WAS RUN AGAIN AND RECOVERED LOW. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S LAB. THE ISE SYSTEM WAS CULTURED AND FOUND TO BE CONTAMINATED WITH PSEUDOMONAS. THE FSE DECONTAMINATED THE ISE SYSTEM, REPLACED THE K TIP AND CARBON BRIDGE. AS OF (B) (4) 2008, NO FURTHER LOW K RESULTS WERE GENERATED. A CLEAR ROOT CAUSE HAS NOT BEEN DETERMINED FOR THIS EVENT. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT. (B) (4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC (BCI) REGARDING ERRONEOUSLY LOW POTASSIUM (K) RESULTS GENERATED BY THE UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEMS FOR MULTIPLE PTS. ERRONEOUSLY LOW K RESULTS WERE REPORTED OUT OF THE LAB FOR SEVENTEEN (17) PTS. THE RESULTS WERE IN THE RANGE OF 3.0-4.9 MMOL/L (B) (4). CUSTOMER RECALIBRATED THE ION SELECTIVE ELECTRODE (ISE) SYSTEM, RAN QC WITH ACCEPTABLE RESULTS AND RE-TESTED THE SAMPLES. REPEATED K RESULTS WERE HIGHER AND 17 AMENDED REPORTS WERE ISSUED. (B) (4). THE CUSTOMER STATED TREATMENT WAS NOT INITIATED OR WITHHELD ON ANY PTS BASED ON THE LOW K RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEMS CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER, INC. DXC 600 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA