BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATELLICA CH

    MDR report key: 22112775 · Received May 30, 2025

    Report

    Report Number
    2432235-2025-00141
    Event Type
    Malfunction
    Date Received
    May 30, 2025
    Report Date
    June 12, 2025
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JGS
    UDI-DI
    00630414596518
    PMA / PMN Number
    K222438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION (04-JUN-2025): SIEMENS HEALTHCARE DIAGNOSTICS CONCLUDED THE INVESTIGATION OF THE EVENT. SIEMENS REVIEWED THE AVAILABLE INSTRUMENT DATA FILES, AND THE INFORMATION PROVIDED BY THE CUSTOMER. CALIBRATION WAS ACCEPTABLE, AND QUALITY CONTROL (QC) RECOVERED WITHIN RANGE ON THE EVENT DATE(S). SIEMENS REVIEW OF THE INSTRUMENT DATA INDICATED THAT THE CUSTOMER PERFORMED DILUTION CHECKS BUT DID NOT SAVE THE FACTOR. AS A RESULT, THE FACTOR REMAINED AT 1 ON 07-MAY-2025 WHEN THE DILUTION CHECK WAS PERFORMED. THE CUSTOMER STATED THAT THE ISSUE WAS RESOLVED BY PERFORMING THE INTEGRATED MULTISENSOR TECHNOLOGY (IMT) DILUTION CHECK TO OBTAIN A NEW DILUTION CHECK FACTOR. BASED ON THE AVAILABLE INFORMATION, THE CAUSE OF THE EVENT IS UNKNOWN. A PRODUCT ISSUE WAS NOT IDENTIFIED. THE CUSTOMER IS OPERATIONAL. THE DEVICE IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION IS REQUIRED. SECTION H6 HAS BEEN UPDATED TO REFLECT THE SIEMENS INVESTIGATION. CORRECTION: THE PRODUCT CODE WAS INADVERTENTLY SELECTED AS ¿CEM¿ INSTEAD OF ¿JGS¿ IN THE INITIAL MDR. SECTION D2B HAS BEEN UPDATED TO REFLECT THE CORRECT INFORMATION. INITIAL MDR 2432235-2025-00141 WAS FILED ON 30-MAY-2025.

    Additional Manufacturer Narrative · 0

    A UNITED STATES (US) CUSTOMER CONTACTED THE SIEMENS HEALTHCARE DIAGNOSTICS REMOTE SERVICES CENTER (RSC) REGARDING AN INCREASE IN ELEVATED SODIUM (NA) RESULTS ON MULTIPLE PATIENT SAMPLES, INCLUDING AN ERRONEOUSLY ELEVATED NA RESULT OBTAINED ON A PATIENT SAMPLE ON AN ATELLICA CI 1900 ANALYZER. SIEMENS IS EVALUATING THE EVENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO SIEMENS THAT THEY OBSERVED AN INCREASE IN ELEVATED SODIUM (NA) RESULTS ON MULTIPLE PATIENT SAMPLES, INCLUDING AN ERRONEOUSLY ELEVATED NA RESULT OBTAINED ON A PATIENT SAMPLE ON AN ATELLICA CI 1900 ANALYZER. THE ERRONEOUS RESULT WAS REPORTED TO THE PHYSICIAN(S), AND THE RESULT WAS QUESTIONED. THE SAME SAMPLE WAS REPROCESSED ON THE ORIGINAL ATELLICA CI 1900 ANALYZER AND ON AN ALTERNATE ATELLICA CI 1900 ANALYZER. THE REPROCESSED RESULTS OBTAINED WERE CONSIDERED CORRECT. A CORRECTED REPORT WAS ISSUED. THE CUSTOMER NO LONGER RECALLED CERTAIN DETAILS, SUCH AS THE DATE OF TESTING AND THE REPROCESSED RESULT(S) FOR THE AFFECTED SAMPLE, AS THE EVENT OCCURRED SEVERAL MONTHS AGO. FOR THE OTHER ELEVATED SAMPLES, IT IS UNCLEAR WHETHER ANY ERRONEOUS RESULTS WERE OBTAINED, AS THE PATIENT RESULTS DATA WERE NOT PROVIDED TO SIEMENS AND THE CUSTOMER COULD NOT RECALL ANY DETAILS, INCLUDING SAMPLE IDENTIFIERS, DATE(S) OF TESTING, OR THE RESULTS OBTAINED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12391 ATELLICA CH ATELLICA CH A-LYTE INTEGRATED MULTISENSOR (IMT NA K CL) JGS SIEMENS HEALTHCARE DIAGNOSTICS INC. N/A 150001 00630414596518

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown