BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 880I SYNCHRON ® ACCESS CLINICAL SYSTEM

    MDR report key: 3516269 · Received December 11, 2013

    Report

    Report Number
    2050012-2013-00812
    Event Type
    Malfunction
    Date Received
    December 11, 2013
    Date of Event
    November 22, 2013
    Report Date
    November 22, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    MZV
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S SITE. THE FSE EVALUATED THE INSTRUMENT AND DISCOVERED A CRACK IN THE FLOWCELL, ADJACENT TO THE POTASSIUM (K) ELECTRODE PORT. THE FSE PROCEEDED TO REPLACE THE FLOWCELL TO RESOLVE THE ISSUE. ALTHOUGH IT IS UNKNOWN HOW THE FLOWCELL BECAME CRACKED, THE INSTRUMENT PROVIDED MULTIPLE INDICATIONS OF THE ISSUE, WITH CALIBRATION FAILURES, QUALITY CONTROL (QC) FAILURES, AND FLAGGED RESULTS. THE CUSTOMER CONTINUED TO REPORT PATIENT RESULTS DESPITE THESE INDICATORS. RESULTS: FLOWCELL.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING FALSE HIGH POTASSIUM (K) RESULTS FOR FOURTEEN (14) PATIENT SAMPLES FROM THE UNICEL DXC 880I SYNCHRON ACCESS CLINICAL SYSTEM. THE CUSTOMER REPORTED THE RESULTS OUT OF THE LABORATORY AND ONE (1) PATIENT WAS TREATED BASED UPON A FALSE HIGH K RESULT. THIS REPORT REFERENCES THE OTHER THIRTEEN (13) PATIENTS INVOLVED IN THIS EVENT; PLEASE REFER TO MEDWATCH REPORT #2050012-2013-00813 FOR THE REPORT OF THE PATIENT WHO WAS TREATED. THE CUSTOMER REPEATED THE SAMPLES ON AN ALTERNATE ANALYZER AND ISSUED AMENDED REPORTS. THERE WAS NO CHANGE OR AFFECT TO TREATMENT FOR THE THIRTEEN PATIENTS REFERENCED IN THIS REPORT. QUALITY CONTROL (QC) RESULTS PRIOR TO THE EVENT EXHIBITED IMPRECISION. POTASSIUM QC PRIOR TO THE EVENT RECOVERED 8.7 MMOL/L AND REPEATED AT 7.5 MMOL/L (MEAN WAS 7.5 MMOL/L). PATIENT SAMPLES WERE THEN RUN AND K QC FOLLOWING THE SAMPLE RUN RECOVERED AT 9.3 AND 8.4 MMOL/L. THE CUSTOMER RECALIBRATED THE INSTRUMENT AND K QC RECOVERED AT 7.4 AND 7.6 MMOL/L. THE CUSTOMER THEN RAN PATIENT SAMPLES AGAIN. A REVIEW OF THE CUSTOMER'S INSTRUMENT DATA LOG INDICATED THAT THE SYSTEM HAD MULTIPLE CALIBRATION FAILURES STARTING ON (B)(6) 2013 THROUGH THE DAY OF THE EVENT. IN ADDITION TO THE ERRATIC QC AND CALIBRATION FAILURES, ON THE DAY OF THE EVENT, THE INSTRUMENT ALSO FLAGGED INTERMITTENT K RESULTS WITH A "SAMPLE REFERENCE DRIFT" FLAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648351 UNICEL® DXC 880I SYNCHRON ® ACCESS CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE MZV BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1