BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AU680 CLINICAL CHEMISTRY ANALYZER

    MDR report key: 4171581 · Received October 14, 2014

    Report

    Report Number
    9612296-2014-00129
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Date of Event
    September 23, 2014
    Report Date
    September 24, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K961274
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S SITE. THE FSE EVALUATED THE INSTRUMENT AND REPLACED THE MIXER MOTOR AND REFERENCE BLOCK TO RESOLVE THE ISSUE. THE FSE PERFORMED SEVERAL PRECISION RUNS AND OBTAINED RESULTS WHICH WERE WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ERRONEOUSLY HIGH URINE ELECTROLYTE RESULTS WERE GENERATED FOR MULTIPLE PATIENTS OVER TWO (2) DAYS FROM THE AU680 CLINICAL CHEMISTRY ANALYZER. THIS REPORT REFERENCES THE EVENT WHICH OCCURRED ON (B)(6) 2014; PLEASE REFER TO MEDWATCH REPORT #9612296-2014-00128 FOR THE REPORT OF THE EVENT WHICH OCCURRED ON (B)(6) 2014. THE CUSTOMER STATED THAT PATIENT RESULTS WERE RELEASED OUTSIDE THE LABORATORY. HOWEVER, THERE WAS NO REPORT OF ANY CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. THE CUSTOMER STATED THAT QUALITY CONTROL (QC) WAS PERFORMED DAILY AND RECOVERY WAS WITHIN THE ESTABLISHED LIMIT OF THE LABORATORY. THE CUSTOMER ALSO INDICATED THAT MAINTENANCE WAS LAST PERFORMED ON THE ANALYZER ON SEPTEMBER 23, 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649937 AU680 CLINICAL CHEMISTRY ANALYZER ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER AU680 WITH ISE MODULE NA

    Patients

    Seq Age Sex Outcome Treatment
    1