BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 1882155 · Received October 25, 2010

    Report

    Report Number
    2050012-2010-01040
    Event Type
    Malfunction
    Date Received
    October 25, 2010
    Date of Event
    October 4, 2010
    Report Date
    October 25, 2010
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC WAS WITHIN THE ESTABLISHED RANGES PRIOR TO AND AFTER THE EVENT. A BCI CUSTOMER TECHNICAL SUPPORT (CTS) REVIEWED THE DATA AND NOTIFIED THE CUSTOMER THAT THE SUPPRESSED DATA WITH ORDAC LO FLAG WERE MISINTERPRETED. THE CTS EXPLAINED TO THE CUSTOMER THE ORDAC FLAGS AND THE OPERATOR TIPS SHEET THAT DESCRIBES THE VARIOUS CODES AND TROUBLESHOOTING TIPS. THE CUSTOMER STATED THAT THEY WILL CONDUCT TRAINING ON ORDAC LO FLAGS, THE TRIGGERS FOR ORDAC, AND SAMPLE HANDLING. THE ROOT CAUSE FOR THIS EVENT WAS A CUSTOMER ERROR.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC (BCI) IN REGARDS TO TWO LOW ALANINE AMINOTRANSFERASE (ALT) RESULTS GENERATED BY UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER. THE RESULTS WERE REPORTED OUT OF THE LABORATORY AND QUESTIONED BY THE PHYSICIAN. THE CUSTOMER MISINTERPRETED RESULTS FLAGGED WITH ORDAC LO AND REPORTED AS < 5 IU/L. THE CUSTOMER REPEATED THE TESTS BY DILUTING THE SAMPLES WITH SALINE AND AMENDED THE REPORTS WITH CORRECT RESULTS. THE PATIENT TREATMENT WAS NOT AFFECTED BY THE WRONG RESULTS. NOTE: PER BCI INSTRUCTIONS FOR USE, ORDAC LO MEANS THE REACTION EXCEEDS THE RANGE OF ORDAC (OVER RANGE DETECTION AND CORRECTION) VALUES THAT THE INSTRUMENT WILL REPORT. BCI LABELING ALSO PROVIDES INSTRUCTIONS HOW TO HANDLE AND RERUN THE ORDAC LO SAMPLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER CLINICAL CHEMSTRY ANALYZER JJE BECKMAN COULTER, INC. DXC 800 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention