BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATELLICA CH 930 ANALYZER

    MDR report key: 18639189 · Received February 5, 2024

    Report

    Report Number
    2432235-2024-00026
    Event Type
    Malfunction
    Date Received
    February 5, 2024
    Date of Event
    December 21, 2023
    Report Date
    February 5, 2024
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    JJE
    UDI-DI
    00630414002163
    PMA / PMN Number
    K151767
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER (CCC) AND REPORTED THAT A FALSELY ELEVATED POTASSIUM (K) AND FALSELY DEPRESSED SODIUM (NA) RESULTS WERE OBTAINED ON A PATIENT SAMPLE ON THE ATELLICA CH 930 ANALYZER. SIEMENS REVIEWED THE INSTRUMENT FILES AND DETERMINED THAT DUE TO RESULT FLAGGING AND SAMPLE INTEGRITY RULES, THE RESULTS FOR THIS SAMPLE WERE HELD BY THE ATELLICA DATA MANAGER. AT THIS TIME, THERE IS NO EVIDENCE OF AN INSTRUMENT MALFUNCTION. THE CAUSE OF THE FALSELY ELEVATED K AND FALSELY DEPRESSED NA RESULTS IS UNKNOWN.

    Description of Event or Problem · 0

    A FALSELY ELEVATED POTASSIUM (K) AND A FALSELY DEPRESSED SODIUM (NA) RESULTS WERE OBTAINED ON A PATIENT SAMPLE ON THE ATELLICA CH 930 ANALYZER. THE ERRONEOUS RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON THE SAME INSTRUMENT. THE REPEAT RESULTS MATCHED THE PATIENT¿S PREVIOUS RESULTS AND CLINICAL PICTURE. THE REPEAT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED K AND FALSELY DEPRESSED NA RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1571981 ATELLICA CH 930 ANALYZER ATELLICA CH 930 ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC ATELLICA CH 930 ANALYZER 00630414002163

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male