BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS DIGOXIN

    MDR report key: 1971380 · Received January 27, 2011

    Report

    Report Number
    1823260-2011-00433
    Event Type
    Malfunction
    Date Received
    January 27, 2011
    Date of Event
    November 30, 2010
    Report Date
    May 20, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    KXT
    PMA / PMN Number
    K973112
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A ROOT CAUSE FOR THIS EVENT COULD NOT BE DETERMINED. SEVEN SAMPLES WERE RETURNED FOR INVESTIGATION. 5 PATIENT SAMPLES AND 2 TEA SAMPLES. THE POSITIVE RESULTS FOR ALL 5 PATIENT SAMPLES COULD NOT BE CONFIRMED. THE 2 TEA SAMPLES WERE DETERMINED POSITIVE. AS TEA IS AN AQUEOUS SAMPLE AND NOT AN APPROVED SAMPLE MATERIAL, THE POSITIVE RESULTS COULD BE AN ARTIFIACT. QUALITY CONTROL RESULTS CONNECTED TO THE SAMPLES RESULTS WERE NOT AVAILABLE TO DETERMINE IF A LOCAL ISSUE CONTRIBUTED TO THE FALSELY ELEVATED SAMPLES. ADDITIONAL PATIENT SAMPLE MATERIAL GIVING A CLEAR POSITIVE RESULT WAS NOT AVAILABLE FOR FURTHER INVESTIGATION. A POSITIVE DIGOXIN RESULT ON A PATIENT WITHOUT DIGOXIN TREATMENT WOULD BE DETECTED AND MAY LEAD TO FURTHER VERIFICATION. IN THIS CASE MEDICAL RISK DUE TO THE FALSE POSITIVE DIGOXIN RESULT WAS LESS THAN REMOTE.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER CONDUCTED A DIGOXIN STUDY INVOLVING AN UNKNOWN NUMBER OF BOTH MALE AND FEMALE PARTICIPANTS. THE PARTICIPANTS WERE APPROXIMATELY (B)(6) AND IN GOOD HEALTH. THE STUDY TOOK PLACE DURING THE END OF (B)(6) 2010. POSITIVE DIGOXIN RESULTS WERE GENERATED FROM PARTICIPANTS THAT DID NOT TAKE DIGOXIN. THESE PARTICIPANTS DID DRINK DIFFERENT KINDS OF FRUIT TEAS; THEREFORE THE TEA WAS ANALYZED USING THIS COBAS E411 ANALYZER AND YIELDED A DIGOXIN RESULT OF 0.6 NG/ML. THE FRUIT TEA DID NOT CONTAIN DIGOXIN WHEN MEASURED WITH A HIGH PERFORMANCE LIQUID CHROMATOGRAPHY MASS SPECTROMETER (HPLC-MS). NONE OF THE PARTICIPANTS WERE HARMED BY THE ERRONEOUS RESULTS. THE SERIAL NUMBER OF THE COBAS E411 ANALYZER WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECSYS DIGOXIN ENZYME IMMUNOASSAY KXT ROCHE DIAGNOSTICS NA 15625001

    Patients

    Seq Age Sex Outcome Treatment
    1