BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGOXIN

    MDR report key: 18857499 · Received March 7, 2024

    Report

    Report Number
    1823260-2024-00697
    Event Type
    Malfunction
    Date Received
    March 7, 2024
    Date of Event
    February 6, 2024
    Report Date
    August 21, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    KXT
    UDI-DI
    07613336121214
    PMA / PMN Number
    K961824
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COBAS C 503 ANALYTICAL UNIT SERIAL NUMBER WAS (B)(6) . THE CUSTOMER TESTED OTHER SAMPLES THAT WERE EXPECTED TO BE NEGATIVE AND THE RESULTS WERE BETWEEN 0.35 AND 0.55 UG/L. THE CUSTOMER THEN REPLACED THE REGENT AND RECALIBRATED THE ASSAY. THE RESULTS WERE THEN NEGATIVE. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION FOUND THE LAST ASSAY CALIBRATION BEFORE THE EVENT WAS PERFORMED ON 14-DEC-2023. PER PRODUCT LABELING, A FULL CALIBRATION IS TO BE PERFORMED AFTER REAGENT LOT CHANGE OR AS REQUIRED FOLLOWING QUALITY CONTROL PROCEDURES. IN PREVIOUS INVESTIGATIONS, IT WAS FOUND THAT THE RECOVERY OF CALIBRATOR B WITH A CONCENTRATION OF 0.5 DRIFTED FROM 95% TO 118% WITHIN 7 WEEKS. THE CUSTOMER DATA SHOWS A DRIFT OF APPROXIMATELY 0.2 NG/ML WITHIN 6 -8 WEEKS. THE INVESTIGATION DETERMINED THE DRIFT COULD INFLUENCE LOW VALUES AROUND THE LIMIT OF QUANTITATION (LOQ) OF 0.4 NG/ML AND SAMPLES WITH RESULTS INITIALLY FOUND BELOW THE LOQ WHEN MEASURED SHORTLY AFTER CALIBRATION CAN GENERATE RESULTS ABOVE THE LOQ IF MEASURED AT A LATER POINT AFTER CALIBRATION.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF A QUESTIONABLE DIGOXIN RESULT FROM THE COBAS C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 0.45 G/L FOR A SAMPLE THAT WAS EXPECTED TO HAVE A NEGATIVE RESULT. AS THE RESULTS DID NOT AGREE WITH THE PATIENT'S CLINICAL PICTURE, THE SAMPLE WAS SENT TO ANOTHER LABORATORY WHERE IT WAS TESTED WITH ABBOTT METHODOLOGY AND WITH MASS SPECTROMETRY. NO SPECIFIC DATA WAS PROVIDED, BUT THE RESULTS WERE CONSIDERED TO BE NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2195332 DIGOXIN ENZYME IMMUNOASSAY, DIGOXIN KXT ROCHE DIAGNOSTICS 72471501 07613336121214

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown