BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNICEL® DXC 880I SYNCHRON ® ACCESS CLINICAL SYSTEM

    MDR report key: 3516267 · Received December 11, 2013

    Report

    Report Number
    2050012-2013-00813
    Event Type
    Injury
    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
    Adverse Event
    Yes
    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.

    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 THE REPORTED FALSE HIGH K RESULT. THIS REPORT REFERENCES THE ONE (1) PATIENT WHO WAS TREATED IN THIS EVENT; PLEASE REFER TO MEDWATCH REPORT #2050012-2013-00812 FOR THE REPORT OF THE OTHER THIRTEEN (13) PATIENTS. THE PATIENT WAS TREATED BASED UPON A FALSE HIGH K RESULT OF 6.2 MMOL/L. THE PHYSICIAN ADMINISTERED INSULIN TO THE PATIENT TO REDUCE THE K CONCENTRATION AND THE PATIENT SUFFERED A CARDIAC ARREST AS A RESULT. THE PATIENT SURVIVED. THE CUSTOMER REPEATED THE ORIGINAL SAMPLE ON AN ALTERNATE ANALYZER AND OBTAINED A K RESULT OF 5.0 MMOL/L 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
    646986 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 Life Threatening| O