BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2143398 · Received June 29, 2011

    Report

    Report Number
    2122870-2011-01992
    Event Type
    Malfunction
    Date Received
    June 29, 2011
    Date of Event
    May 6, 2011
    Report Date
    May 31, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    LGD
    PMA / PMN Number
    K023764
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE CUSTOMER SUPPLIED QC CHARTS, BOTH LEVELS OF TOXO IGG QC HAVE BEEN WITHIN THE CUSTOMER'S ESTABLISHED RANGES. HOWEVER, THE CUSTOMER DID NOT SUPPLY QC DATA FROM THE DATE OF THE EVENT. A ROUTINE SYSTEM CHECK WAS PERFORMED ON (B)(4) 2011 WHICH PASSED WITHIN INSTRUMENT SPECIFICATIONS. THERE IS NO INDICATION THAT SERVICE WAS DISPATCHED FOR THIS EVENT. A CLEAR ROOT CAUSE CAN NOT BE DETERMINED FOR THIS EVENT BASED ON THE INFORMATION PROVIDED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC (BEC), REGARDING ERRATIC EQUIVOCAL AND NON-REACTIVE TOXO IGG RESULTS GENERATED BY THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM FOR ONE PATIENT. THE RESULTS DID NOT MEET THE EXPECTED PRECISION CLAIMS OF THE ASSAY. THE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER LGD BECKMAN COULTER INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO