BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 2243152 · Received September 12, 2011

    Report

    Report Number
    2050012-2011-04960
    Event Type
    Malfunction
    Date Received
    September 12, 2011
    Date of Event
    August 3, 2011
    Report Date
    August 12, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PER CUSTOMER CONTACT, THE REVIEW OF CUSTOMER DATA FOR THE SAMPLE IN QUESTION COMPARING TO A NORMAL SAMPLE, THIS APPEARS TO BE A SAMPLE INTERFERENCE ISSUE. THE CUSTOMER PERFORMED QC PRIOR TO THIS INCIDENT AND THE RESULTS WERE WITHIN 2 STANDARD DEVIATION (SD). SERVICE WAS NOT REQUESTED FOR THIS EVENT. THIS IS A POSSIBLE SAMPLE INTERFERENCE ISSUE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) STATING THAT THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM GENERATED A <5 MG/DL, OIR - LO (OUT OF INSTRUMENT RANGE - LOW) RESULT ON ONE (1) PATIENT SAMPLE. THE ERRONEOUS RESULT WAS NOT REPORTED OUT OF THE LABORATORY. THE CUSTOMER SENT THE SAMPLE TO A REFERENCED LAB WHICH YIELDED A BELIEVABLE RESULT OF 38 MG/DL. TREATMENT WAS NOT INITIATED OR WITHHELD BASED UPON THE FALSE HIGH RESULTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXC 600I N/A

    Patients

    Seq Age Sex Outcome Treatment
    1