BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATELLICA CH 930 ANALYZER

    MDR report key: 22802287 · Received August 14, 2025

    Report

    Report Number
    2432235-2025-00210
    Event Type
    Malfunction
    Date Received
    August 14, 2025
    Date of Event
    July 22, 2025
    Report Date
    September 8, 2025
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    JJE
    UDI-DI
    00630414002163
    PMA / PMN Number
    K151767
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A UNITED STATES (US) CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC) AND REPORTED THAT ERRONEOUS CONCENTRATED CARBON DIOXIDE (CO2_C) RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES ON AN ATELLICA CH 930 ANALYZER. QUALITY CONTROL (QC) WAS OUT OF RANGE ON THE DAY OF THE EVENT. THE CUSTOMER PERFORMED CALIBRATION WHICH RECOVERED QC ACCEPTABLY. SIEMENS ASSISTED THE CUSTOMER AND CHECKED THE WATER SYSTEM AND FOUND LOW RESISTIVITY. THE CUSTOMER PERFORMED THE WATER TREATMENT PROCEDURE TO ADDRESS LOW RESISTIVITY, AND THE INSTRUMENT IS OPERATIONAL. SIEMENS IS EVALUATING THE EVENT.

    Additional Manufacturer Narrative · 0

    SIEMENS FILED INITIAL MDR 2432235-2025-00210 ON 14-AUG-2025. ADDITIONAL INFORMATION ON 15-AUG-2025: SIEMENS REVIEWED THE INSTRUMENT DATA FILES, WHICH SHOWED FLUCTUATIONS IN MILLI-ABSORBANCE UNIT (MAU) READINGS ASSOCIATED WITH POOR WATER QUALITY. THE INSTRUMENT DATA ALSO SHOWED THAT CONCENTRATED CARBON DIOXIDE (CO2_C) CALIBRATIONS HAD MAU VALUES TYPICAL FOR THE ASSAY. QUALITY CONTROL (QC) RESULTS AFTER CALIBRATION WERE WITHIN RANGE AND CONSISTENT. SIEMENS FURTHER EVALUATED THE EVENT AND DETERMINED THAT THE LOW RESISTIVITY OF THE DISTILLED WATER SUPPLIED BY THE LABORATORY WATER SYSTEM POTENTIALLY CONTRIBUTED TO THE ERRONEOUS CO2_C RESULTS. THIS WATER SYSTEM IS NOT MAINTAINED BY SIEMENS HEALTHINEERS. AFTER THE WATER SYSTEM WAS SERVICED, THE PERFORMANCE OF THE CO2_C ASSAY RECOVERED TO ACCEPTABLE LEVELS. THE INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSIONS CODE IN SECTION H6 WERE UPDATED TO REFLECT ADDITIONAL INFORMATION. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT ERRONEOUS CONCENTRATED CARBON DIOXIDE (CO2_C) RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES ON AN ATELLICA CH 930 ANALYZER. THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED ON THE ORIGINAL ATELLICA CH 930 ANALYZER AND OBTAINED RESULTS WHICH WERE CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUS CO2_C RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    865769 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 NA Unknown