BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AU5400 CLINICAL CHEMISTRY ANALYZER (AU5431-02 UG ANALYZER)

    MDR report key: 3011392 · Received March 19, 2013

    Report

    Report Number
    9612296-2013-00042
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    February 19, 2013
    Report Date
    February 19, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    NDW
    PMA / PMN Number
    K011720
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BEC CUSTOMER TECHNICAL SUPPORT (CTS) INFORMED THE CUSTOMER THAT THE PROBLEM IS RELATED TO THE REAGENT BOTTLES AND THE MOVEMENT OF THE BOTTLES IN THE COMPARTMENT. THE CUSTOMER OBSERVED THAT THE BOTTLES APPEARED TO BE MALFORMED. CTS RECOMMENDED THE CUSTOMER TO POUR THE REAGENT INTO A WHITE BOTTLE AND RUN AS A FIXED REAGENT. THE CUSTOMER STATED THAT CHANGED THE BOTTLE ELIMINATED THE PROBLEM. THE CUSTOMER NO LONGER HAS THE DEFECTED BOTTLES BECAUSE THEY WERE SCRAPPED. A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED FOR THIS EVENT. THE FSE NOTED THAT THE CUSTOMER REPLACED THE SAMPLE PROBE AND R1 PROBE AND CHECKED THE SYRINGES PRIOR TO ARRIVAL. THE FSE RECHECKED THE PROBES, SYRINGES, AND ALIGNMENTS. THE CUSTOMER CALIBRATED AND RAN QUALITY CONTROL (QC); ALL YIELDED WITHIN LIMITS. THE FSE PERFORMED SEVERAL ADJUSTMENTS AND REPLACED MULTIPLE PARTS; HOWEVER ERRATIC RECOVERY OF PATIENT SAMPLES STILL REMAINS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) IN REGARDS TO OBTAINING ERRONEOUSLY ELEVATED LITHIUM (LI+) PATIENT RESULTS GENERATED ON THE (B)(4) UG CLINICAL CHEMISTRY ANALYZER. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. THE CUSTOMER CONFIRMED THAT FOUR (4) CORRECTED REPORTS WERE ISSUED FOR THIS EVENT. THE CUSTOMER DID NOT PROVIDE PATIENT DATA FOR THIS EVENT. THERE IS NO REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED TO OR CONNECTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114713 AU5400 CLINICAL CHEMISTRY ANALYZER (AU5431-02 UG ANALYZER) ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE NDW BECKMAN COULTER AU5431-02 UG N/A

    Patients

    Seq Age Sex Outcome Treatment
    1