BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AU5400 CLINICAL CHEMISTRY ANALYZER

    MDR report key: 2658710 · Received July 17, 2012

    Report

    Report Number
    2050012-2012-01569
    Event Type
    Malfunction
    Date Received
    July 17, 2012
    Date of Event
    June 23, 2012
    Report Date
    June 23, 2012
    Manufacturer
    BECKMAN COULTER MISHIMA K.K.
    Product Code
    JJE
    PMA / PMN Number
    K011720
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER INC ASSESSMENT OF CUSTOMER SUPPLIED REACTION MONITOR DATA INDICATED ABNORMAL RESULTS FOR THE CREATININE ASSAY. OPTICAL DENSITY READINGS OF THE TEST PROCESS REMAIN UNCHANGED AFTER A SPECIFIC POINT IN THE PROCESS, INDICATING THAT NO FURTHER REACTION OCCURRED AFTER A DEFINED POINT IN THE TESTING PROCESS. THE CAUSE OF THIS EVENT IS LACK OF APPROPRIATE REACTION FOR CREATININE ASSAY; HOWEVER, THE REASON FOR THE ABNORMALITIES IN THE REACTION IS UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AN ERRONEOUS ELEVATED CREATININE RESULT WAS GENERATED FROM AN AU5400 CLINICAL CHEMISTRY ANALYZER FOR A SINGLE PATIENT. THE ERRONEOUSLY ELEVATED, INITIAL CREATININE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE PHYSICIAN REFERRED THE PATIENT TO A NEPHROLOGIST. THERE IS NO EVIDENCE THAT ANY CHANGE TO MEDICAL TREATMENT OCCURRED DUE TO THIS REFERRAL. THE ONLY EVIDENCE PROVIDED WAS THAT THE PATIENT WAS RETESTED FOR CREATININE, AS THE PATIENT WAS REDRAWN AND RETESTED BY ANOTHER LABORATORY AND THE INITIAL RESULT WAS FOUND TO BE INCORRECT BASED UPON THE FOLLOW-UP TESTING RESULT. THERE WAS NO DEATH, SERIOUS INJURY OR MODIFICATION TO PATIENT TREATMENT ASSOCIATED OR ATTRIBUTED TO THIS EVENT. THE ORIGINAL SAMPLE WAS SUBSEQUENTLY RETESTED ON THE AU5400 CLINICAL CHEMISTRY ANALYZER AND THE REPEAT RESULT CONCURRED WITH THE ALTERNATE LABORATORY'S RESULT. BECKMAN COULTER INC ASSESSMENT OF CUSTOMER SUPPLIED DATA INCLUDED ADDITIONAL PATIENTS' RESULTS, HOWEVER, THESE RESULTS WERE NOT QUESTIONED AS PART OF THIS EVENT. THE INITIAL SAMPLE RESULT INVOLVED IN THIS EVENT WAS ELEVATED. UPON RETEST AND FOLLOW-UP TESTING, BOTH SUBSEQUENT RESULTS WERE LOWER AND CONSIDERED VALID. A CORRECTED REPORT WAS ISSUED. THE SAMPLE WAS AN ADEQUATELY SEPARATED SERUM SPECIMEN WITH GEL SEPARATOR. THERE WAS ADEQUATE SERUM HEIGHT. QUALITY CONTROL RESULTS DURING THE TIMEFRAME OF THIS EVENT MET CUSTOMER ESTABLISHED SPECIFICATIONS. NO CUVETTE OVERFLOW WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AU5400 CLINICAL CHEMISTRY ANALYZER ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER MISHIMA K.K. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR