BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 SYNCHRON® SYSTEM

    MDR report key: 2250543 · Received September 16, 2011

    Report

    Report Number
    2050012-2011-05298
    Event Type
    Malfunction
    Date Received
    September 16, 2011
    Date of Event
    August 23, 2011
    Report Date
    August 23, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS DISPATCHED TO THE SITE FOR THIS EVENT. THE FIELD SERVICE ENGINEER (FSE) REPLACED THE CALC TIP AND ELECTRODE AND CLEANED THE PORT. THE INSTRUMENT WAS RETURNED INTO SERVICE AFTER THE NECESSARY AND VERIFIED REPAIRS HAD BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON (B)(6) 2011 ERRONEOUSLY LOW CALCIUM (CALC) RESULTS WERE GENERATED ON A UNICEL DXC 600 SYNCHRON SYSTEM FOR AN UNKNOWN PATIENT SAMPLES. ACTUAL SAMPLE RESULTS WERE NOT PROVIDED BY THE CUSTOMER. UPON REPEAT, THE CALC RESULT WAS HIGHER, NEAR HISTORICAL PATIENT MEANS, REGARDED AS VALID, AND REPORTED OUTSIDE OF THE LABORATORY. THE ERRONEOUS CALC RESULTS WERE NOT RELEASED FROM THE LABORATORY. THERE WAS NO DEATHS, SERIOUS INJURIES OR CHANGES TO PATIENT TREATMENT ASSOCIATED OR ATTRIBUTED TO THIS EVENT. THE CUSTOMER HAD INDICATED THAT THERE WERE PRIOR SIMILAR ISSUES WITH THE INSTRUMENT HOWEVER NO DETAILS WERE PROVIDED REGARDING THESE PRIOR EVENTS. INSTRUMENT ASSAY QUALITY CONTROL RESULTS WERE WITHIN CUSTOMER ESTABLISHED SPECIFICATIONS AT THE TIMEFRAME OF THE EVENT. NO PATIENT SPECIFIC INFORMATION, SAMPLE COLLECTION/HANDLING INFORMATION, OR ADDITIONAL SYSTEM INFORMATION WAS PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600 SYNCHRON® SYSTEM ANALYZER, CHEMISTRY JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1