BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AU5400 CLINICAL CHEMISTRY ANALYZER

    MDR report key: 4244461 · Received November 11, 2014

    Report

    Report Number
    9612296-2014-00135
    Event Type
    Injury
    Date Received
    November 11, 2014
    Date of Event
    October 4, 2014
    Report Date
    October 17, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    DCK
    PMA / PMN Number
    K011720
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER'S REVIEW OF THE CUSTOMER'S OPTICAL DENSITY READINGS OF THE CRP ASSAY BETWEEN CALIBRATIONS INDICATES STABLE AND CONSISTENT RECOVERIES AT EACH LEVEL. THERE IS NO INDICATION OF A REAGENT ISSUE. A FIELD SERVICE ENGINEER (FSE) WAS NOT DISPATCHED TO THE CUSTOMER'S SITE FOR THIS EVENT; NO PARTS WERE REPLACED, AND NO ADJUSTMENTS OR ALIGNMENTS WERE PERFORMED. THE CUSTOMER CONFIRMED THAT WITH THE EXCEPTION THIS EVENT, THE INSTRUMENT HAS PERFORMED WITHOUT ANY ISSUES PRIOR TO AND FOLLOWING THE EVENT. THE CUSTOMER HAS NOT BEEN ABLE TO REPRODUCE THIS EVENT. IN CONCLUSION, THE CAUSE OF THE EVENT IS UNKNOWN; THERE IS NO EVIDENCE OF A REAGENT OR MECHANICAL INSTRUMENT MALFUNCTION. THIS EVENT WAS ISOLATED TO CRP. THE COMPLETE PATIENT IDENTIFIER FOR THIS REPORT IS (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING ERRONEOUSLY ELEVATED C REACTIVE PROTEIN (CRP) RESULTS FOR MULTIPLE PATIENT SAMPLES FROM THE AU5400 CLINICAL CHEMISTRY ANALYZER. THE ERRONEOUS CRP RESULTS WERE REPORTED OUT OF THE LABORATORY AND THE CUSTOMER HAD CONFIRMED THAT ONE (1) PATIENT, WHO WAS ADMITTED TO THE HOSPITAL FOR CHEMOTHERAPY, HAD AN ANTIBIOTIC TREATMENT STARTED AS A RESULT OF THE ERRONEOUSLY ELEVATED CRP RESULT. BECKMAN COULTER IS UNAWARE OF ANY ADDITIONAL CONSEQUENCE TO THE PATIENT AS A RESULT OF THE TREATMENT. THE CUSTOMER HAS NOT RECEIVED ANY FURTHER REPORTS OF CHANGE OR AFFECT TO PATIENT TREATMENT. THE CUSTOMER INDICATED THAT NO ISSUES WERE NOTED WITH ANY OTHER ASSAYS. THE CUSTOMER STATED THAT QUALITY CONTROL (QC) RESULTS PRIOR TO THE EVENT PASSED WITHIN THE LABORATORY'S ESTABLISHED RANGES. LEVEL 1 QC RESULT FOR CRP WAS OUT HIGH FOLLOWING THE EVENT WITH A RESULT OF 36.8 MG/L AND AN EXPECTED TARGET OF 6.6 MG/L. THE OPERATOR CONCLUDED THAT LEVEL 1 QC HAD BEEN INCORRECTLY POURED AND SUBSEQUENT REPEAT OF THE QC WITH A FRESH QC SAMPLE GENERATED ACCEPTABLE RESULTS. ALL CRP PATIENT RESULTS WERE THEN REPORTED OUT OF THE LABORATORY. WHEN THE CUSTOMER WAS ALERTED OF THE ERRONEOUS CRP RESULTS, THE CUSTOMER REVIEWED THE PATIENT RESULTS AND REPEATED THE PATIENT SAMPLES. THE CUSTOMER STATED THAT ONLY SIX (6) SAMPLES WERE CONFIRMED AS ELEVATED AND EIGHTY-THREE (83) RESULTS WERE FOUND TO HAVE "NORMAL OR ALMOST NORMAL" VALUES. THE CUSTOMER ISSUED CORRECTED REPORTS OUT OF THE LABORATORY. THE CUSTOMER DID NOT PROVIDE ANY REPEAT RESULTS FOR THIS EVENT. BECKMAN COULTER REVIEWED THE REACTION MONITOR'S OPTICAL DENSITY (OD) READINGS AND IDENTIFIED THAT THE OD READINGS DO NOT CORRESPOND WITH THE GENERATED RESULT VALUES. BECKMAN COULTER RE-CALCULATED THE CRP RESULTS BASED ON THE OD READINGS MEASURED BY THE ANALYZER AND DETERMINED THAT SEVENTY-SIX (76) RESULTS WERE DEEMED ERRONEOUSLY HIGH BASED ON THE RE-CALCULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725889 AU5400 CLINICAL CHEMISTRY ANALYZER ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE DCK BECKMAN COULTER AU5421-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other