BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGOXIN

    MDR report key: 2241898 · Received September 9, 2011

    Report

    Report Number
    1823260-2011-04827
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    August 24, 2011
    Report Date
    January 23, 2012
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    KXT
    PMA / PMN Number
    K961824
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT DETERMINE A SPECIFIC ROOT CAUSE. NO ADVERSE EVENT WAS REPORTED.

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    THE FIELD APPLICATION SPECIALIST REPORTED THE USER EXPERIENCED AN ISSUE WITH ERRATIC QUALITY CONTROL FOR DIGOXIN THAT WAS ONGOING SINCE (B)(6) 2011. THE USER ALSO RECEIVED A QUESTIONABLE DIGOXIN RESULT FOR ONE PATIENT SAMPLE THAT OCCURRED ON (B)(6) 2011. ALL RESULTS WERE ACCOMPANIED BY DATA FLAGS. THE INITIAL RESULT WAS <0.17 NG/ML FROM COBAS C501 ANALYZER (B)(4). THE SAMPLE WAS REPEATED ON THE SAME COBAS C501 ANALYZER AND THE RESULT WAS 0.42 NG/ML. THE SAMPLE WAS THEN TESTED ON COBAS C501 ANALYZER (B)(4) WITH A RESULT OF 0.39 NG/ML. THE RESULT OF 0.39 NG/ML WAS DEEMED CORRECT AND WAS REPORTED OUTSIDE THE LABORATORY. THE SAMPLE WAS THEN TESTED FIVE ADDITIONAL TIMES ON THE ORIGINAL COBAS C501 ANALYZER WITH RESULTS OF 0.38 NG/ML, 0.45 NG/ML, 0.42 NG/ML, 0.54 NG/ML AND 0.37 NG/ML. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THERE WAS A DEFECTIVE REAGENT CASSETTE. THE USER AND THE FIELD APPLICATION SPECIALIST REPLACED THE REAGENT CASSETTE, RAN QUALITY CONTROL AND RETESTED PATIENT SAMPLES TO DETERMINE THE PROBLEM WAS RESOLVED. THE FIELD SERVICE REPRESENTATIVE VERIFIED THE ANALYZER HARDWARE WORKED PROPERLY BY RUNNING PRECISION TESTING. THE FIELD APPLICATION SPECIALIST DETERMINED THERE WAS A POSSIBLE REAGENT PACK MIXING ERROR AS THE QUALITY CONTROL SHOWED SPORADIC RESULTS WHEN THE CASSETTE WAS PLACED INTO USE. SHE PLACED A NEW REAGENT PACK OF THE SAME LOT NUMBER ON THE REAGENT ROTATOR FOR 10 MINUTES, PLACED ON BOARD, CALIBRATED AND RAN QUALITY CONTROL. CALIBRATION AND QUALITY CONTROL PASSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIGOXIN ENZYME IMMUNOASSAY, DIGOXIN KXT ROCHE DIAGNOSTICS NA 64175801

    Patients

    Seq Age Sex Outcome Treatment
    1