BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA® CHEMISTRY CARBON DIOXIDE CONCENTRATED (CO2_C) REAGENT

    MDR report key: 20026271 · Received August 22, 2024

    Report

    Report Number
    2432235-2024-00183
    Event Type
    Malfunction
    Date Received
    August 22, 2024
    Date of Event
    August 5, 2024
    Report Date
    September 24, 2024
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    KHS
    PMA / PMN Number
    K100289
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN OUTSIDE UNITED STATES (OUS) CUSTOMER CONTACTED THE SIEMENS HEALTHCARE DIAGNOSTICS CUSTOMER CARE CENTER (CCC) REGARDING A FALSELY ELEVATED CARBON DIOXIDE CONCENTRATED (CO2_C) PATIENT RESULT OBTAINED ON AN ADVIA CHEMISTRY XPT INSTRUMENT. SIEMENS HEALTHCARE DIAGNOSTICS IS INVESTIGATING THE EVENT.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION (03-SEP-2024): SIEMENS HEALTHCARE DIAGNOSTICS HEADQUARTERS SUPPORT CENTER (HSC) CONCLUDED THE INVESTIGATION OF THE EVENT. A CUSTOMER SERVICE ENGINEER (CSE) INSPECTED THE ADVIA CHEMISTRY XPT INSTRUMENT AND IDENTIFIED CONTAMINATION IN THE OIL BATH AND LAMP ISSUE. THE CSE RESOLVED THE ISSUE BY PERFORMING STANDARD TROUBLESHOOTING, WHICH WAS REMOVING THE CONTAMINATION FROM THE OIL BATH AND REPLACING THE LAMP. A POTENTIAL PRODUCT ISSUE WAS NOT IDENTIFIED. THE CUSTOMER IS OPERATIONAL. THE DEVICE IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION IS REQUIRED. IN SECTION H6, THE INVESTIGATION FINDING AND INVESTIGATION CONCLUSION CODES WERE UPDATED. INITIAL MDR 2432235-2024-00183 WAS FILED ON 16-AUG-2024.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSELY ELEVATED CARBON DIOXIDE CONCENTRATED (CO2_C) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ADVIA CHEMISTRY XPT INSTRUMENT. THE ERRONEOUS PATIENT SAMPLE RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAMPLE WAS REPROCESSED ON THE INITIAL ADVIA CHEMISTRY XPT INSTRUMENT AND AN ALTERNATE ADVIA CHEMISTRY XPT INSTRUMENT. LOWER RESULTS WERE OBTAINED, CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUS ELEVATED CARBON DIOXIDE CONCENTRATED (CO2_C) RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2178679 ADVIA® CHEMISTRY CARBON DIOXIDE CONCENTRATED (CO2_C) REAGENT ENZYMATIC, CARBON-DIOXIDE KHS SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 160

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female