BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIG DIGOXIN

    MDR report key: 10592143 · Received September 28, 2020

    Report

    Report Number
    1823260-2020-02366
    Event Type
    Malfunction
    Date Received
    September 28, 2020
    Date of Event
    August 24, 2020
    Report Date
    September 28, 2020
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    KXT
    PMA / PMN Number
    K961824
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). THE SAMPLE WAS REQUESTED FOR INVESTIGATION, HOWEVER, THERE WAS NO SAMPLE MATERIAL REMAINING FOR INVESTIGATION. CALIBRATION AND QC WERE ACCEPTABLE. THE PATIENT¿S MEDICATIONS (DUE TO THE NATURE AND STRUCTURE) WERE EXCLUDED AS INTERFERING WITH THE ASSAY. SINCE CALIBRATION AND QC WERE ACCEPTABLE, BOTH REAGENT AND INSTRUMENT ISSUES WERE EXCLUDED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. PRODUCT LABELING STATES: "IN RARE INSTANCES (<1 %), SAMPLES CONTAIN UNIDENTIFIED COMPONENTS WHICH CAUSE NON SPECIFIC AGGLUTINATION IN THIS ASSAY. THESE SAMPLES GIVE FALSELY LOWERED DIGOXIN VALUES." SINCE THE SAMPLE COULD NOT BE PROVIDED, THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR DIG DIGOXIN (DIG) ON A COBAS 6000 C (501) MODULE. THE INITIAL RESULT FROM THE C501 MODULE WAS 0.06 NG/ML WITH A DATA FLAG. THE SAMPLE WAS REPEATED ON THE SAME MODULE WITH A RESULT OF 0.09 NG/ML WITH A DATA FLAG. THESE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY WHERE THEY WERE QUESTIONED BY THE DOCTOR AS THE PATIENT WAS "AN OLD HOSPITALIZED WOMAN" TAKING DIGOXIN. ON 26-AUG-2020 AN ALIQUOT OF THE SAMPLE WAS SENT TO ANOTHER HOSPITAL WHERE IT WAS TESTED BY THE SIEMENS VISTA METHOD, AND THE RESULT WAS 1.62 NG/ML. THIS RESULT WAS BELIEVED TO BE CORRECT. ON 03-SEP-2020 ANOTHER ALIQUOT OF THE SAMPLE WAS SENT TO ANOTHER HOSPITAL WHERE IT WAS TESTED ON A COBAS E801 MODULE, AND THE RESULT WAS 1.70 NG/ML. THIS RESULT CONFIRMED THE RESULT FROM THE SIEMENS METHOD. THE C501 MODULE SERIAL NUMBER WAS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1058068 DIG DIGOXIN ENZYME IMMUNOASSAY, DIGOXIN KXT ROCHE DIAGNOSTICS NA 49238601

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR CEFTRIAXONE| DIGOXIN| HEPARIN| LASIX