BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 660I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 2961976 · Received February 14, 2013

    Report

    Report Number
    2050012-2013-00084
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    January 22, 2013
    Report Date
    January 22, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    QC PRIOR TO THE EVENT WAS WITHIN THE LAB-ESTABLISHED RANGES. QC RUN AFTER THE HIGH RESULTS WERE NOTICED WAS OUT OF RANGE HI, >2 S.D. (APPROXIMATELY THE SAME MAGNITUDE AS THE PATIENT RESULTS). MAINTENANCE AND RECALIBRATION OF THE ASSAY DID NOT RESOLVE THE ISSUE. HOTLINE HAD THE CUSTOMER REPLACE THE CALC ELECTRODE TIP. THIS RESOLVED THE ISSUE AND SERVICE WAS NOT INITIATED FOR THIS EVENT. THE CALC ELECTRODE TIP WAS NOT DUE TO BE REPLACED FOR ANOTHER FORTY FOUR (44) DAYS. FAILURE MODE OF THIS EVENT WAS THE CALC ELECTRODE TIP.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) TO REPORT THAT THE UNICEL DXC 660I SYNCHRON ACCESS CLINICAL SYSTEM GENERATED FALSE HIGH CALC (CALCIUM) RESULTS FOR ELEVEN (11) PATIENT SAMPLES. THE RESULTS WERE REPORTED OUT OF THE LAB. WHEN THE ISSUE WAS NOTICED, THE SAMPLES WERE RERUN FOR CALC ON ANOTHER ANALYZER IN THE CUSTOMER LAB AND THE REPORTS WERE AMENDED. NEITHER DEATH NOR INJURY WAS REPORTED IN CONNECTION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65640 UNICEL® DXC 660I SYNCHRON® ACCESS® CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER DXC 660I NA

    Patients

    Seq Age Sex Outcome Treatment
    1