BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AU5431-02 CLINICAL CHEMISTRY ANALYZER

    MDR report key: 1919003 · Received December 10, 2010

    Report

    Report Number
    2050012-2010-01577
    Event Type
    Injury
    Date Received
    December 10, 2010
    Date of Event
    November 5, 2010
    Report Date
    November 10, 2010
    Manufacturer
    BECKMAN COULTER MISHIMA K.K.
    Product Code
    JJE
    PMA / PMN Number
    K011720
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC WAS WITHIN RANGE PRIOR TO THE EVENT BUT WAS OUT OF RANGE AFTER THE EVENT. A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE AND PERFORMED TROUBLESHOOTING. FSE INDICATED THAT THE PROBLEM WAS DUE TO A BAD SAMPLE VALVE FOR THE OUTER WHEEL AND REPLACED THE SAMPLE VALVE. THE SAMPLE VALVE WAS ORIGINAL TO THE INSTRUMENT AND WAS ON THE SYSTEM FOR AT LEAST 9 YEARS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING ERRONEOUSLY HIGH IRON RESULTS FOR 24 PATIENTS GENERATED BY THE AU5431-02 CLINICAL CHEMISTRY ANALYZER. THE RESULTS WERE REPORTED OUTSIDE THE LABORATORY AND CORRECTED REPORTS WERE ISSUED AFTER REPEAT TESTING WAS PERFORMED. IT IS UNKNOWN IF PATIENT TREATMENT WAS AFFECTED IN THIS EVENT. THE RISK OF SERIOUS INJURY WILL BE ASSUMED UPON RECUR. A SEPARATE REPORT 2050012-2010-01660 HAS BEEN SUBMITTED FOR THE MALFUNCTION PORTION OF THIS EVENT AND THE REPORTS SHOWN BELOW HAVE BEEN SUBMITTED FOR THE OTHER PATIENTS ASSOCIATED WITH THIS EVENT. 2050012-2010-01540; 2050012-2010-01556; 2050012-2010-01557; 2050012-2010-01558; 2050012-2010-01559; 2050012-2010-01560; 2050012-2010-01561; 2050012-2010-01562; 2050012-2010-01563; 2050012-2010-01564; 2050012-2010-01565; 2050012-2010-01566; 2050012-2010-01567; 2050012-2010-01568; 2050012-2010-01569; 2050012-2010-01570; 2050012-2010-01571; 2050012-2010-01572; 2050012-2010-01573; 2050012-2010-01574; 2050012-2010-01575; 2050012-2010-01576; 2050012-2010-01578.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AU5431-02 CLINICAL CHEMISTRY ANALYZER CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER MISHIMA K.K. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other