BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BECKMAN DIRECT BILIRUBIN REAGENT

    MDR report key: 4735132 · Received April 28, 2015

    Report

    Report Number
    2050010-2015-00002
    Event Type
    Malfunction
    Date Received
    April 28, 2015
    Date of Event
    April 1, 2015
    Report Date
    April 2, 2015
    Manufacturer
    BECKMAN COULTER
    Product Code
    CIG
    PMA / PMN Number
    K934068
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER WAS NOT DISPATCHED. THE SAMPLE WAS TESTED ON THE AU5800 CLINICAL CHEMISTRY SYSTEM, WHICH GENERATED BELIEVABLE RESULTS. BECKMAN (BEC) CHEMISTRY TECHNICAL APPLICATIONS REVIEWED THE CUSTOMER'S DATA AND FOUND EVIDENCE OF AN UNIDENTIFIED INTERFERENT PRESENT IN THE SAMPLE. (B)(6).

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FALSE HIGH RESULT WAS GENERATED FROM THE BECKMAN DIRECT BILIRUBIN REAGENT KIT (DBIL) WHEN USED ON THE UNICEL DXC 800 PRO SYNCHRON SYSTEM. THE RESULT WAS QUESTIONED BECAUSE IT WAS HIGHER THAN THE TOTAL BILIRUBIN (TBIL) RESULT FROM THE SAME SAMPLE. THE SAMPLE WAS RERUN ON A DIFFERENT DXC 800 PRO SYNCHRON SYSTEM WITH SIMILAR RESULTS. THERE WAS NO IMPACT TO PATIENT TREATMENT. THE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. CONTROLS (QC) WERE RUN BEFORE AND AFTER THIS EVENT AND THE RESULTS WERE WITHIN RANGES. NO OTHER SAMPLES WERE AFFECTED. THE SAMPLE WAS TESTED ON THE AU5800 CLINICAL CHEMISTRY ANALYZER WHICH GENERATED BELIEVABLE RESULTS. PLEASE REFER TO MDR 2050010-2015-00001 FOR THE EVENT RELATED TO TBIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278487 BECKMAN DIRECT BILIRUBIN REAGENT DIAZO COLORIMETRY, BILIRUBIN CIG BECKMAN COULTER NA M310075

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR