BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATELLICA CH

    MDR report key: 19654454 · Received July 2, 2024

    Report

    Report Number
    2432235-2024-00146
    Event Type
    Malfunction
    Date Received
    July 2, 2024
    Date of Event
    June 11, 2024
    Report Date
    July 24, 2024
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    KHS
    UDI-DI
    00630414595900
    PMA / PMN Number
    K100289
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION (02-JUL-2024): SIEMENS HEALTHCARE DIAGNOSTICS HEADQUARTERS SUPPORT CENTER (HSC) REVIEWED THE INSTRUMENT DATA FILES. UPON REVIEWING THE INSTRUMENT DATA, IT WAS IDENTIFIED THAT FOUR (4) ADDITIONAL ERRONEOUSLY ELEVATED CARBON DIOXIDE, CONCENTRATED (CO2_C) RESULTS ON THE SAME FOUR (4) PATIENT SAMPLES WERE OBTAINED ON THE EVENT DATE WHEN THE SAMPLES WERE REPROCESSED ON THE ORIGINAL ATELLICA CH 930 ANALYZER. SECTION B6 HAS BEEN UPDATED TO REFLECT THE CORRECT INFORMATION. ADDITIONAL INFORMATION (02-JUL-2024): SIEMENS HEALTHCARE DIAGNOSTICS HEADQUARTERS SUPPORT CENTER (HSC) CONCLUDED THE INVESTIGATION OF THE EVENT. HSC REVIEWED THE INSTRUMENT DATA FILES AND THE INFORMATION PROVIDED BY THE CUSTOMER. HSC REVIEWED THE ASPIRATION OF REAGENTS AND SAMPLES AND OBSERVED NO ATYPICAL PATTERNS. NO ISSUES WERE OBSERVED WITH THE ATELLICA CH 930 ANALYZER AND NO ISSUES WERE OBSERVED WITH THE CO2 REAGENT. THE CAUSE OF THE EVENT IS UNKNOWN. THE ANALYZER IS OPERATIONAL. THE DEVICE IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION IS REQUIRED. SECTION H6 HAS BEEN UPDATED TO REFLECT THE HSC INVESTIGATION. INITIAL MDR 2432235-2024-00146 WAS FILED ON 02-JUL-2024.

    Additional Manufacturer Narrative · 0

    A UNITED STATES (US) CUSTOMER CONTACTED THE SIEMENS HEALTHCARE DIAGNOSTICS REMOTE SERVICES CENTER (RSC) REGARDING ERRONEOUSLY ELEVATED CARBON DIOXIDE, CONCENTRATED (CO2_C) RESULTS ON FOUR (4) PATIENT SAMPLES OBTAINED ON AN ATELLICA CH 930 ANALYZER. SIEMENS IS INVESTIGATING THE EVENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO SIEMENS THAT THEY OBTAINED ERRONEOUSLY ELEVATED CARBON DIOXIDE, CONCENTRATED (CO2_C) RESULTS ON FOUR (4) PATIENT SAMPLES ON AN ATELLICA CH 930 ANALYZER. THE ERRONEOUSLY ELEVATED RESULTS WERE REPORTED TO THE PHYSICIAN(S), AND THE RESULTS WERE QUESTIONED. THE SAME SAMPLES WERE REPROCESSED ON THE ORIGINAL ATELLICA CH 930 ANALYZER. LOWER REPROCESSED RESULTS WERE OBTAINED AND CONSIDERED CORRECT. CORRECTED REPORTS WERE ISSUED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY ELEVATED CARBON DIOXIDE, CONCENTRATED (CO2_C) RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570964 ATELLICA CH ATELLICA CH CARBON DIOXIDE, CONCENTRATED (CO2_C) KHS SIEMENS HEALTHCARE DIAGNOSTICS INC. N/A 130399 00630414595900

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown