BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 2598121 · Received June 5, 2012

    Report

    Report Number
    2122870-2012-01360
    Event Type
    Injury
    Date Received
    June 5, 2012
    Date of Event
    May 7, 2012
    Report Date
    May 8, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K060256
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS DISPATCHED TO THE SITE. THE FIELD SERVICE ENGINEER (FSE) PERFORMED A HIGH SENSITIVITY SYSTEM CHECK THAT FAILED TO PERFORM WITHIN SPECIFICATIONS. THE FSE REPLACED THE INSTRUMENT ASPIRATE PROBES AND ASPIRATE PROBE TUBING TO RESOLVE THE FAILING HIGH SENSITIVITY SYSTEM CHECK PERFORMANCE. THE FSE REPORTED THEY WERE ABLE TO OBTAIN PASSING HIGH SENSITIVITY SYSTEM CHECK RESULTS AFTER THE HARDWARE REPLACEMENTS. UPON THE COMPLETION OF THE NECESSARY AND VERIFIED REPAIRS, THE INSTRUMENT WAS RETURNED BACK INTO OPERATION. A DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE. MDRS ASSOCIATED WITH THIS EVENT: 2122870-2012-01360, 2122870-2012-01371, 2122870-2012-01361.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ERRONEOUSLY ELEVATED CARDIAC TROPONIN (ACCUTNI) RESULTS, WITHIN THE RISK STRATIFICATION RANGE OF THE ASSAY, WERE GENERATED ON THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM FOR EIGHT PATIENTS. THIS REPORT REPRESENTS THE ERRONEOUSLY ELEVATED ACCUTNI RESULT GENERATED FOR ONE PATIENT THAT CAUSED A MODIFICATION TO PATIENT TREATMENT. THE INITIAL ERRONEOUS ACCUTNI RESULT WAS REPORTED OUTSIDE OF THE LABORATORY AND A STRESS TEST AND HEPARIN THERAPY WAS ADMINISTERED. BECKMAN COULTER INC. ASSESSMENT OF CUSTOMER SUPPLIED DATA INDICATED THAT REPEAT TESTING ON AN ALTERNATE INSTRUMENT PRODUCED A LOWER ACCUTNI RESULT, WITHIN THE NORMAL REFERENCE RANGE, WHICH WAS REGARDED AS VALID. THE SAMPLE WAS COLLECTED IN A LITHIUM HEPARIN PRIMARY TUBE AND WAS CENTRIFUGED PRIOR TO TESTING. THE SAMPLE WAS REFRIGERATED DURING STORAGE AND WAS ALIQUOTED AND RECENTRIFUGED PRIOR TO RETEST. THE CUSTOMER DID NOT REPORT ANY SAMPLE INTEGRITY CONCERNS WITH THE SAMPLE. BECKMAN COULTER INC. ASSESSMENT OF CUSTOMER SUPPLIED INSTRUMENT PERFORMANCE DATA INDICATED THAT INSTRUMENT ACCUTNI QUALITY CONTROL (QC) RESULTS FAILED TO MEET CUSTOMER ESTABLISHED SPECIFICATION ON THE DATE OF THE EVENT. A SYSTEM CHECK PERFORMED ON THE DATE OF THE EVENT GENERATED ACCEPTABLE RESULTS. THE REAGENT AND CALIBRATOR LOTS ASSOCIATED WITH THIS EVENT WERE 122054 AND 121451 RESPECTIVELY

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention