BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BECKMAN TOTAL BILIRUBIN TRIGGERED (TB-T) KIT

    MDR report key: 4735150 · Received April 28, 2015

    Report

    Report Number
    2050010-2015-00001
    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
    K902801
    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

    .

    Additional Manufacturer Narrative · 1

    THE REAGENT WAS NOT RETURNED FOR EVALUATION. 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. INITIAL REPORTER'S TELEPHONE NUMBER:(B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FALSE LOW RESULT WAS GENERATED FROM THE BECKMAN TOTAL BILIRUBIN TRIGGERED (TB-T) (ALSO KNOWN AS TBIL) REAGENT KIT WHEN USED ON THE UNICEL DXC 800 PRO SYNCHRON SYSTEM. THE RESULT WAS QUESTIONED BECAUSE IT WAS LOWER THAN THE DIRECT BILIRUBIN (DBIL) 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. THE DBIL RESULT WAS BELIEVED TO BE ERRONEOUS AS WELL, PLEASE REFER TO MDR 2050010-2015-00002 FOR THE EVENT RELATED TO DBIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278004 BECKMAN TOTAL BILIRUBIN TRIGGERED (TB-T) KIT DIAZO COLORIMETRY, BILIRUBIN CIG BECKMAN COULTER NA M407248

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR