BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AU600 CLINICAL CHEMISTRY ANALYZER

    MDR report key: 3586210 · Received January 21, 2014

    Report

    Report Number
    9612296-2014-00011
    Event Type
    Malfunction
    Date Received
    January 21, 2014
    Date of Event
    December 30, 2013
    Report Date
    December 30, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JGS
    PMA / PMN Number
    K961274
    Removal / Correction Number
    Z-0152-0153-2014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER PROVIDED CALIBRATION AND QUALITY CONTROL DATA COLLECTED PRIOR TO THE EVENT. THE DATA WAS REVIEWED: CALIBRATION SLOPES GENERATED WERE LOW BUT WITHIN SPECIFIED RANGE (-38 TO -68) PRIOR TO THE EVENT ON (B)(6) 2013. QUALITY CONTROL DATA GENERATED WAS ALSO WITHIN TARGETS PRIOR TO THE EVENT. ON (B)(4) 2013, THE FIELD SERVICE ENGINEER (FSE) EVALUATED THE ANALYZER AND DETERMINED THE REFERENCE VALVE WAS ALLOWING BUBBLES INTO THE FLOW CELL INTERMITTENTLY. THE FSE REPLACED THE REFERENCE VALVE AND PRIMED THE SYSTEM A NUMBER OF TIMES. NO FURTHER BUBBLES WERE OBSERVED. THE LOW CALIBRATION SLOPES ALSO IMPROVED AS A RESULT OF THE REFERENCE VALVE CHANGE. IDENTIFICATION OF FAILURE MODE: THE ERRONEOUS SODIUM RESULTS WERE MOST LIKELY CAUSED BY AN ISE REFERENCE VALVE MALFUNCTION. AS PER CUSTOMER LETTER FSN - URGENT FIELD SAFETY NOTICE 21338-1 : INACCURATE TEST RESULTS MAY BE GENERATED DUE TO THE PRESENCE OF AIR BUBBLES IN THE ISE REF SOLUTION TUBING. THE MAGNITUDE OF ERROR CANNOT BE PREDICTED. AFFECTED RESULTS MAY BE CLINICALLY SIGNIFICANT (HIGH OR LOW) AND MAY IMPACT PATIENT DIAGNOSIS AND/OR TREATMENT.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED ERRONEOUS LOW SODIUM TEST RESULTS WERE OBTAINED FOR APPROXIMATELY 30 PATIENT SAMPLES WHEN USING THE AU680 CLINICAL CHEMISTRY ANALYZER. THE CUSTOMER STATED THAT THESE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY; HOWEVER, THERE WERE NO REPORTS OF ADVERSE AFFECTS TO PATIENT TREATMENT. THE TEST RESULTS WERE DEEMED TO BE ERRONEOUSLY LOW AFTER BEING QUESTIONED BY A PHYSICIAN AND THE SAMPLES WERE RETESTED. THERE WAS NO DEATH OR INJURY REPORTED FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47067 AU600 CLINICAL CHEMISTRY ANALYZER ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JGS BECKMAN COULTER AU681-10E NA

    Patients

    Seq Age Sex Outcome Treatment
    1