BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 880I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 2230320 · Received September 1, 2011

    Report

    Report Number
    2050012-2011-03997
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    July 7, 2011
    Report Date
    July 7, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    CGA
    PMA / PMN Number
    K060256
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S SITE ON (B)(4) 2011. THE FSE REPLACED THE MODULAR CHEMISTRY (MC) SAMPLE PROBE, T-VALVE, AND GLUCOSE REAGENT SYRINGE. THE FSE ALSO OBSERVED A SAMPLE INTEGRITY PROBLEM -- ONE PATIENT SAMPLE FOR (B)(4) 2011 CONTAINED FIBRIN IN THE SAMPLE TUBE. A FSE WAS DISPATCHED AGAIN TO THE CUSTOMER'S SITE ON (B)(6) 2011. NO INSTRUMENT HARDWARE WAS REPLACED DURING THIS VISIT. THE FSE OBSERVED THAT THE GLUCOSE MODULE WAS PERFORMING ACCORDING TO SPECIFICATIONS WITH A STANDARD DEVIATION OF 0.3 AND A COEFFICIENT OF VARIATION OF 0.6%. THE ROOT CAUSE FOR THIS EVENT HAS NOT YET BEEN DETERMINED. THIS MEDWATCH REPORT IS RELATED TO ANOTHER MEDWATCH REPORT FILED FOR A SIMILAR EVENT BUT ON A DIFFERENT DATE. THE RELATED MEDWATCH REPORT NUMBER IS 2050012-2011-03998.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BEC) TO REPORT DISCREPANT GLUCOSE MODULE (GLUCM) RESULTS FOR FOUR (4) PATIENTS GENERATED BY THEIR UNICEL DXC 880I SYNCHRON ACCESS CLINICAL SYSTEM. THE CUSTOMER REPORTED THAT THE DISCREPANT GLUCM RESULTS FOR THE FOUR (4) PATIENTS WERE REPORTED OUT OF THE LABORATORY. THERE WAS NO REPORT OF IMPACT TO PATIENT TREATMENT ATTRIBUTED TO THIS EVENT. AT THE TIME LEADING UP TO THE EVENT, THE CUSTOMER REPORTED THAT QUALITY CONTROL (QC) RESULTS FOR GLUCM WERE RECOVERING HIGH WITH RESPECT TO THE LABORATORY'S ESTABLISHED RANGES. THE DISCREPANT PATIENT SAMPLE RESULTS FOR GLUCM WERE RECOVERING LOWER THAN EXPECTED. REPEAT ANALYSES GENERATED HIGHER EXPECTED GLUCM RESULTS WHICH WERE REPORTED OUT OF THE LABORATORY IN AMENDED REPORTS. THE DISCREPANT GLUCM RESULTS FOR THE FOUR (4) PATIENT SAMPLES OCCURRED OVER TWO DAYS. THIS MEDWATCH REPORT COVERS DAY 1 OF 2 ((B)(6) 2011) ADDRESSING RESULTS FOR THREE (3) PATIENT SAMPLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 880I SYNCHRON® ACCESS® CLINICAL SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER CGA BECKMAN COULTER, INC. DXC 880I NA

    Patients

    Seq Age Sex Outcome Treatment
    1