BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BECKMAN COULTER AU600 CLINICAL CHEMISTRY ANALYZER

    MDR report key: 2902476 · Received January 8, 2013

    Report

    Report Number
    9612296-2013-00001
    Event Type
    Malfunction
    Date Received
    January 8, 2013
    Date of Event
    December 17, 2012
    Report Date
    December 17, 2012
    Manufacturer
    BECKMAN COULTER MISHIMA K.K.
    Product Code
    JJE
    PMA / PMN Number
    K961274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) ASSISTED THE CUSTOMER WITH TROUBLESHOOTING OVER THE PHONE. EVALUATION CODE - METHOD: THE CUSTOMER PERFORMED REPAIRS AS SUGGESTED BY THE FIELD SERVICE ENGINEER (FSE) OVER THE PHONE. EVALUATION - CONCLUSIONS: THE CUSTOMER REPORTED THAT REPLACING THE PARTS SUGGESTED BY THE FIELD SERVICE ENGINEER (FSE) HAD RESOLVED THE ISSUE. THE CUSTOMER CALLED BACK ON (B)(6) 2012 TO REPORT ANOTHER LOW SODIUM (NA) RECOVERY. PLEASE SEE MEDWATCH #9612296-2013-00002 FOR THE REPORT OF THE EVENT WHICH OCCURRED ON (B)(6) 2012. EVALUATION WAS DONE OVER THE PHONE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ISSUES WITH LOW SODIUM (NA) RECOVERY FROM A BECKMAN COULTER AU600 CLINICAL CHEMISTRY ANALYZER. THE CUSTOMER STATED THAT NA QUALITY CONTROL (QC) RESULTS ARE ON TARGET BUT DRIFTS LOWER OVER THE COURSE OF THE DAY. THREE CORRECTED RESULTS WERE ISSUED BY THE LABORATORY BUT THE CUSTOMER INDICATED THAT THE LABORATORY HAS RECEIVED NO REPORTS OF ANY AFFECT TO PATIENT OR PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. UPON REVIEW OF THE PATIENT PRINTOUTS PROVIDED BY THE CUSTOMER, BECKMAN COULTER NOTICED THAT CHLORIDE RECOVERY FOR THE PATIENTS WERE ALSO LOW. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) ASSISTED THE CUSTOMER ON THE PHONE AND ADVISED TO REPLACE THE WASTE PUMP TUBING, MID STANDARD ROLLER PUMP TUBING AND PINCH VALVE TUBING. THE CUSTOMER HAD INITIALLY CONFIRMED THAT THE ISSUE APPEARED TO HAVE BEEN ADDRESSED BUT THE CUSTOMER HAD CALLED BACK ON (B)(6) 2012 DUE TO ANOTHER LOW NA RECOVERY ISSUES. PLEASE SEE MEDWATCH #9612296-2013-00002 FOR THE REPORT OF THE EVENT WHICH OCCURRED ON (B)(6) 2012. PATIENT INFORMATION IN PART A OF THIS REPORT IS FROM PATIENT #1 IN THE PROVIDED ATTACHMENT FOR PATIENT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9639 BECKMAN COULTER AU600 CLINICAL CHEMISTRY ANALYZER ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER MISHIMA K.K. AU681-02E

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR