BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALBUMIN BCG METHOD

    MDR report key: 2143296 · Received June 29, 2011

    Report

    Report Number
    1823260-2011-03505
    Event Type
    Malfunction
    Date Received
    June 29, 2011
    Date of Event
    June 16, 2011
    Report Date
    June 28, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CIX
    PMA / PMN Number
    K033009
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE ALBUMIN RESULTS FROM THE ANALYTICAL D MODULE ANALYZER SERIAL NUMBER (B)(4) THAT WERE DISCOVERED WHEN THEY WERE COMPARED TO THE PATIENT'S PREVIOUS RESULTS. THE USER STATED THEY HAD TO CORRECT RESULTS FOR ABOUT 20 PATIENT SAMPLES. HOWEVER, SPECIFIC DATA WAS PROVIDED FOR ONLY ONE PATIENT SAMPLE. THE INITIAL RESULT WAS 2.1 G/DL AND WAS REPORTED OUTSIDE THE LABORATORY. THE REPEAT RESULT WAS 3.5 G/DL. THE PATIENTS WERE NOT ADVERSELY AFFECTED. THE ALBUMIN R2 REAGENT LOT NUMBER WAS 63700201. UPON EVALUATION OF THE ANALYZER, THE FIELD SERVICE REPRESENTATIVE FOUND A PARTIALLY CLOTTED SAMPLE PROBE AND STYLETTED ALL FOUR SAMPLE PROBES. TO VERIFY THE ANALYZER OPERATION, HE PERFORMED PRECISION CHECKS WITH ALL RESULTS WITHIN SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALBUMIN BCG METHOD BROMCRESOL GREEN DYE-BINDING, ALBUMIN CIX ROCHE DIAGNOSTICS NA 63632101

    Patients

    Seq Age Sex Outcome Treatment
    1