BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMAGE® 800 IMMUNOCHEMISTRY SYSTEM

    MDR report key: 2433972 · Received February 1, 2012

    Report

    Report Number
    2050012-2012-00338
    Event Type
    Malfunction
    Date Received
    February 1, 2012
    Date of Event
    January 11, 2012
    Report Date
    January 11, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    OPX
    PMA / PMN Number
    K962294
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) EVALUATED THE ANALYZER AND REPLACED THE SAMPLE PROBE. THE FSE PERFORMED SAMPLE CRANE ALIGNMENTS, VERIFIED BOTH SRYINGES AND CUVETTES, AND RAN MULTIPLE PATIENT SAMPLES AND QUALITY CONTROL. THE PROBABLE CAUSE OF THIS EVENT WAS ATTRIBUTED TO A MALFUNCTION OF THE SAMPLE PROBE. THIS MDR IS ONE OF TWO EVENTS REPORTED BY THIS CUSTOMER. THE RELATED MDR IS 2050012-2012-00337.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ERRONEOUS LOW TEST RESULTS FOR IGM (IMMUNOGLOBULIN M) AND KAPPA WERE OBTAINED FOR ONE PATIENT SAMPLE WHEN USING THE IMMAGE 800 IMMUNOCHEMISTRY SYSTEM. THE ERRONEOUS TEST RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. QUALITY CONTROL DATA PROVIDED BY THE CUSTOMER DEMONSTRATED IMPRECISION. THERE WERE NO REPORTS OF DEATH, SERIOUS INJURY OR AFFECT TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMAGE® 800 IMMUNOCHEMISTRY SYSTEM NEPHELOMETER, FOR CLINICAL USE OPX BECKMAN COULTER, INC. IMMAGE 800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1