BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BECKMAN COULTER AU480 CLINICAL CHEMISTRY ANALYZER

    MDR report key: 3181143 · Received June 21, 2013

    Report

    Report Number
    9612296-2013-00072
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 15, 2013
    Report Date
    May 23, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K981743
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FSE (FIELD SERVICE ENGINEER) WAS DISPATCHED AND DISCOVERED AN ISSUE WITH THE PERISTALTIC PUMP FOR DILUTE DETERGENT. THE FSE STATED THAT THE PUMP WOULD VIBRATE RATHER THAN TURN ROTATIONALLY WHICH DID NOT ALLOW FOR THE PROPER CONCENTRATION DILUTE DETERGENT. THE FSE INSTALLED A NEW PUMP ASSEMBLY TO RESOLVE THE ISSUE. REPAIR WAS VERIFIED PER ESTABLISHED PROCEDURES AND RESULTS MET PUBLISHED SPECIFICATIONS. FAILURE MODE IS ATTRIBUTED TO A DEFECTIVE PERISTALTIC PUMP FOR DILUTE DETERGENT. ALL RELATED MEDWATCH REPORTS ASSOCIATED WITH THIS EVENT: 9612296-2013-00070; 9612296-2013-00071; 9612296-2013-00072.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED MULTIPLE ERRONEOUS PATIENT RESULTS FOR MULTIPLE TESTS, OVER SEPARATE DAYS, INVOLVING THE BECKMAN COULTER AU480 CLINICAL CHEMISTRY ANALYZER. THE CUSTOMER ALSO RECOVERED ERRATIC CALIBRATION AND CONTROL RESULTS FOR THE AFFECTED TESTS, WHICH INCLUDED DIGOXIN, ACETAMINOPHEN, ALCOHOL, GLUCOSE, CALCIUM, AND UIBC (UNSATURATED IRON-BINDING CAPACITY) TESTS. THE CUSTOMER STATED THAT ONE OF THE ERRONEOUS RESULTS WAS REPORTED OUT OF THE LABORATORY BUT THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. THIS REPORT REFERENCES THE EVENT WHICH OCCURRED ON (B)(6) 2013. THE CUSTOMER ATTEMPTED TO RESOLVE THE ISSUE BY REPLACING THE LAMP, SAMPLE PROBE, AND REAGENT PROBE ON (B)(6) 2013 BUT ISSUE WAS NOT RESOLVED. THE CUSTOMER IS PERFORMING WEEKLY MAINTENANCE EVERY WEDNESDAY AND THE LAST MONTHLY MAINTENANCE WAS PERFORMED ON (B)(6) 2013. THE CUSTOMER PROVIDED EXAMPLES OF A FAILED CALIBRATION FOR ACETAMINOPHEN AND A FAILED QC RESULT FOR UIBC WHICH WAS OUT OF THE ESTABLISHED RANGE; THE ORIGINAL UIBC RESULT WAS 64 MICROGRAMS PER DECILITER AND THE REPEAT RESULT WAS 178 MICROGRAM PER DECILITERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282131 BECKMAN COULTER AU480 CLINICAL CHEMISTRY ANALYZER ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER AU481-02E NA

    Patients

    Seq Age Sex Outcome Treatment
    1