BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AU5811-03 CLINICAL CHEMISTRY ANALYZER (230V)

    MDR report key: 3223203 · Received July 12, 2013

    Report

    Report Number
    9612296-2013-00090
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 14, 2013
    Report Date
    June 17, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JGS
    PMA / PMN Number
    K112412
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    QUALITY CONTROL (QC) WAS WITHIN LABORATORY ESTABLISHED RANGE PRIOR TO AND AFTER THE EVENT. THE CALIBRATION SLOPE DATA SHOWED SLIGHTLY ERRATIC RESULTS BUT WERE WITHIN SPECIFICATION. THE APPLICATION SPECIALIST INDICATED THAT NONE OF THE SAMPLES WERE INFLUENCED BY LIPAEMIC, HAEMOLYTIC OR ICTERIC INTERFERENCES. THEY ALSO INDICATED THERE WERE NO ERROR FLAGS GENERATED FOR CLOT DETECTION. A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT AND IDENTIFIED NO SYSTEM MALFUNCTION. THE FSE DID NOT REPLACE ANY PARTS AS NONE WERE DEEMED TO BE DEFECTIVE. THERE WAS NO INDICATION OF USE ERROR AND A DEFINITIVE FAILURE MODE COULD NOT BE DETERMINED. THE ONLY INDICATION OF A SYSTEM MALFUNCTION WAS THE GENERATION OF THE NINETEEN (19) ERRONEOUS RESULTS. BEC CONTINUES TO INVESTIGATE THIS INCIDENT.

    Additional Manufacturer Narrative · 1

    UPDATED 08/14/2013: THE FAILURE MODE FOR THIS EVENT IS INCONCLUSIVE AS THE FSE WAS NOT ABLE TO IDENTIFY A SYSTEM MALFUNCTION. THE CUSTOMER RECENTLY NOTED SAMPLE PREPARATION ISSUES. THE CUSTOMER HAS BEEN USING INSUFFICIENT SAMPLE FOR ANALYSIS. AS A RESULT, THIS HAS CAUSED THE SAMPLE PROBE TO ASPIRATE GEL. THE ASPIRATION OF GEL FROM THE GEL SEPARATOR TUBES COULD LEAD TO ASPIRATION OF INSUFFICIENT SAMPLES AND BLOCKAGES IN THE TUBING. THIS COULD LEAD TO ERRONEOUS SODIUM AND POTASSIUM RESULTS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) IN REGARDS TO OBTAINING ERRONEOUSLY LOW SODIUM (NA) AND POTASSIUM (K) PATIENT RESULTS FOR NINETEEN (19) DIFFERENT PATIENTS GENERATED ON THE AU5811-03 CLINICAL CHEMISTRY ANALYZER (230V). THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. THE SAMPLES WERE RE-RUN YIELDING RESULTS WITHIN THE NORMAL REFERENCE RANGE. THIS INCIDENT WAS ONLY OBSERVED ON THE NA AND K RESULTS WHICH BOTH SHOWED A SIMILAR DEGREE OF 10 - 30 % NEGATIVE BIAS. THERE WERE NO REPORTS OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED TO OR CONNECTED WITH THIS EVENT.

    Description of Event or Problem · 1

    THIS IS A FOLLOW UP REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322887 AU5811-03 CLINICAL CHEMISTRY ANALYZER (230V) ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JGS BECKMAN COULTER AU5800 1U (AU5811-03) NA

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR