BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIG DIGOXIN

    MDR report key: 6030362 · Received October 14, 2016

    Report

    Report Number
    1823260-2016-01571
    Event Type
    Malfunction
    Date Received
    October 14, 2016
    Date of Event
    May 3, 2016
    Report Date
    November 15, 2016
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    KXT
    PMA / PMN Number
    K973112
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS DETERMINED THE CUSTOMER HAD USED THE NON-RESTANDARDIZED VERSION OF THE DIGOXIN ASSAY FOR TESTING ON THE COBAS E602 ANALYZER AND THE RE-STANDARDIZED VERSION OF THE ASSAY ON THE COBAS C501. THE DIFFERENCE IN THE RESULTS BETWEEN THE TWO SYSTEMS WAS DUE TO THE RESTANDARDIZATION OF THE ASSAY AS THE PRIOR REFERENCE STANDARDIZATION USED A NON-OPTIMAL REFERENCE CURVE. BOTH VERSIONS OF THE ASSAY PERFORMED WITHIN THEIR SPECIFICATIONS AND GENERATED RELIABLE RESULTS. THERE WAS NO DEVICE MALFUNCTION.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER DISCOVERED QUESTIONABLE DIG DIGOXIN RESULTS FROM THE COBAS C501 ANALYZER WHEN THEY WERE COMPARED TO THE RESULTS FROM THE COBAS E602 ANALYZER. THE SERIAL NUMBERS OF THE ANALYZERS INVOLVED WERE REQUESTED BUT WERE NOT PROVIDED. THE CUSTOMER HAD BEEN USING THE ASSAY ON THE COBAS C501 ANALYZER AND THE SAMPLES WERE TESTED BETWEEN (B)(6) 2016. ON (B)(6) 2016, THE CUSTOMER SWITCHED TO TESTING THE ASSAY ON THE COBAS E602 ANALYZER. THE SAMPLES WHICH HAD BEEN FROZEN WERE RETESTED ON THE COBAS E602 FOR A CORRELATION. OF THE DATA PROVIDED FOR 20 PATIENT SAMPLES, ONLY THE RESULTS FOR FIVE WERE DISCREPANT. (B)(6). THE RESULTS FROM C501 WERE RELEASED OUT OF LABORATORY. THE PATIENTS WERE NOT ADVERSELY AFFECTED. THE REAGENT LOT USED ON THE E602 WAS 184449. THE EXPIRATION DATES WERE REQUESTED BUT WERE NOT PROVIDED. THE CUSTOMER HAD NOTICED EXTERNAL QC RESULTS ON THE C501 WERE OUTSIDE THE ACCEPTABLE RANGE. WHEN THE CUSTOMER STARTED RUNNING THE ASSAY ON THE E602 THE RESULTS OF THE EXTERNAL QC WERE WITHIN THE SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681873 DIG DIGOXIN ENZYME IMMUNOASSAY, DIGOXIN KXT ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1