BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGOXIN

    MDR report key: 18914795 · Received March 15, 2024

    Report

    Report Number
    1823260-2024-00775
    Event Type
    Malfunction
    Date Received
    March 15, 2024
    Date of Event
    February 27, 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 ANALYZER SERIAL NUMBER WAS (B)(6). THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    DATA WAS PROVIDED FOR AN ADDITIONAL PATIENT SAMPLE FOR DIGOXIN (DIG) THAT DID NOT MATCH THE CLINICAL PICTURE FOR THE PATIENT AS THEY WERE NOT RECEIVING DIGOXIN TREATMENT. ON (B)(6) 2024, THE RESULTS FOR THE PATIENT WERE 0.406 NG/ML AND 0.423 NG/ML.

    Additional Manufacturer Narrative · 0

    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 QUESTIONABLE DIGOXIN (DIG) RESULTS FROM THE COBAS C 503 ANALYTICAL UNIT THAT SIS NOT MATCH THE CLINICAL PICTURE FOR THE PATIENTS. THE CUSTOMER ALLEGED MANY PATIENT SAMPLES HAD RESULTS AROUND 0.4 AND 0.6 WITHOUT ANY DIGOXIN TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    966370 DIGOXIN ENZYME IMMUNOASSAY, DIGOXIN KXT ROCHE DIAGNOSTICS 72471501 07613336121214

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown