BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AU480 CLINICAL CHEMISTRY ANALYZER WITH ISE

    MDR report key: 3831577 · Received May 25, 2014

    Report

    Report Number
    9612296-2014-00082
    Event Type
    Malfunction
    Date Received
    May 25, 2014
    Date of Event
    May 9, 2014
    Report Date
    May 9, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    JGS
    PMA / PMN Number
    K981743
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED. THE FSE CONFIRMED THE LOW ISE RESULTS. FSE IDENTIFIED THE ISE REFERENCE VALVE AS THE CAUSE OF THE INTERMITTENT RESULT ISSUES. REPLACEMENT OF THE VALVE RESOLVED THE ISSUES. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO HOTLINE OF A SINGLE PATIENT WITH ABNORMALLY LOW ISE VALUES. THE SAMPLE WAS REPEATED AND THE LOW RESULTS WERE VALIDATED. CUSTOMER ADDED THAT WITHIN 5 MINUTES ANOTHER LOW ISE PATIENT SAMPLE WAS NOTED. AGAIN THE SAMPLE WAS REPEATED AND THE REPEAT VALUES THIS TIME WERE NORMAL. SODIUM VALUES WERE IN THE CRITICAL LOW RANGE. 2 ERRONEOUS PATIENT RESULTS WERE REPORTED OUT. CUSTOMER CONFIRMED THERE WAS NO MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309763 AU480 CLINICAL CHEMISTRY ANALYZER WITH ISE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JGS BECKMAN COULTER AU481-10E NA

    Patients

    Seq Age Sex Outcome Treatment
    1