BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 3171765 · Received June 17, 2013

    Report

    Report Number
    2122870-2013-00549
    Event Type
    Injury
    Date Received
    June 17, 2013
    Date of Event
    May 16, 2013
    Report Date
    May 17, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    PMA / PMN Number
    K060256
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) DISCOVERED THAT ONE OF THE ASPIRATE PROBES WAS BENT AND BROKEN, WHICH LED TO THE INCOMPLETE ASPIRATION OF THE UNBOUND ANALYTE AND DOSE OVER-RECOVERY OF THE ASSAY. THE FSE REPLACED ALL ASPIRATE AND DISPENSE PROBES AND PERFORMED ALL NECESSARY ALIGNMENTS AND SYSTEM VERIFICATION TESTING. ALL SYSTEM VERIFICATION TESTING PASSED WITHIN THE ASSAY AND INSTRUMENT SPECIFICATIONS. SERVICE ACTIVITY PERFORMED WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS AND WAS RETURNED TO NORMAL OPERATION. NOTE: THE CUSTOMER HAD PERFORMED WEEKLY MAINTENANCE ON THE ANALYZER THE MORNING OF THE EVENT AND ALIGNED THE ASPIRATE PROBES DURING THE PROCEDURE. THIS MEDWATCH REPORT IS RELATED TO MDR 2122870-2013-00548.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ERRONEOUSLY ELEVATED TROPONINI (ACCESS ACCUTNI) RESULTS, WITHIN THE RISK STRATIFICATION, FOR TWO PATIENTS, INVOLVING THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM UTILIZED IN CONJUNCTION WITH THE ACCESS ACCUTNI ASSAY AND CALIBRATOR. THE ERRONEOUS RESULTS WERE RELEASED OUT OF THE LABORATORY. AS A RESULT, THE PATIENTS WERE TRANSFERRED TO AN ALTERNATE FACILITY FOR HIGHER LEVEL OF CARE. IT IS UNKNOWN IF ANY ADDITIONAL TREATMENT WAS GIVEN TO THE PATIENTS. THERE HAS BEEN NO REPORT OF CURRENT PATIENT OUTCOME. QUALITY CONTROL (QC) WAS NOTED TO BE HIGH AND OUT OF RANGE AT THE TIME OF THE EVENT. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) ASSESSED THE INSTRUMENT AT THE FACILITY. THIS IS REPORT TWO OF TWO REFERENCING THE PATIENT ON THE EVENT DATE NOTED. THE CUSTOMER INDICATED THIS PATIENT HAD AN ABNORMAL ELECTROCARDIOGRAM (ECG).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273227 UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE MMI BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization