BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFLOTRON POTASSIUM

    MDR report key: 884466 · Received September 18, 2006

    Report

    Report Number
    1823260-2006-05163
    Event Type
    Malfunction
    Date Received
    September 18, 2006
    Date of Event
    August 21, 2006
    Report Date
    August 29, 2006
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CEJ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE REPORTER CALLED AND ALLEGED DISCREPANT RESULTS ON THE DEVICE WHEN COMPARED TO A LAB. THE RESULTS REPORTED WERE: SEE SCANNED TABLE. CONTROLS WERE OUT OF RANGE AND THE REPORTER SAID CONTROLS WERE RERUN WITH NEWLY RECONSTITUTED CONTROLS WHICH WERE IN RANGE. THE DEVICE WAS REPLACED AND REQUESTED TO BE RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REFLOTRON POTASSIUM CLINICAL CHEMISTRY REAGENT TEST STRIP CEJ ROCHE DIAGNOSTICS NA 23698231

    Patients

    Seq Age Sex Outcome Treatment
    1 * PRECINORM U CONTROL 745154, LOT 17348302| EXP. 4/30/07| EXP. 1/31/07| PRECIPATH U CONTROL 745162, LOT 17235101| REFLOTRON PLUS V 3012573