BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATELLICA CH CARBON DIOXIDE, CONCENTRATED (CO2_C)

    MDR report key: 11724832 · Received April 26, 2021

    Report

    Report Number
    2432235-2021-00100
    Event Type
    Malfunction
    Date Received
    April 26, 2021
    Date of Event
    March 30, 2021
    Report Date
    April 26, 2021
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    KHS
    UDI-DI
    00630414595900
    PMA / PMN Number
    K100289
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER (CCC). QUALITY CONTROLS (QC) RECOVERED IN RANGE AT THE TIME OF THE EVENT, BUT BEGAN TO RISE OVER TIME. A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE CSE VERIFIED REAGENT PROBE 1 AND SAMPLER ALIGNMENTS AND PERFORMED A VISUAL CHECK ON THE FLUIDICS. THE CSE RERAN QC, WHICH RECOVERED ACCEPTABLY. NO SYSTEM ISSUES WERE FOUND. THE SAMPLE COLLECTION INSTRUCTIONS IN THE ATELLICA CARBON DIOXIDE, CONCENTRATED (CO2_C) INSTRUCTIONS FOR USE (IFU) DESCRIBES THAT SAMPLE TUBES SHOULD BE CAPPED AT ALL TIMES (WHEN NOT IN USE). CO2 SAMPLES AT THIS SITE ARE UNCAPPED AND PLACED ONBOARD THE INSTRUMENT AND REMAIN UNCAPPED UNTIL THE RACK HAS FINISHED PROCESSING, WHICH IS AT THE MOST 2 HOURS. TOTAL CARBON DIOXIDE CONCENTRATION MAY BE DECREASED BY 6 MMOL/L WHEN UNCAPPED SPECIMENS ARE EXPOSED TO THE AIR FOR ONE HOUR. THE DATA SUGGESTS THE LOWER RECOVERY ON THE REPEAT RUN IS DUE TO SAMPLE STABILITY AS A RESULT OF EXPOSURE AND THE EQUILIBRATION OF CO2 IN THE SAMPLES TO ROOM AIR. WHILE THE QC REMAINS WITHIN ACCEPTABLE RANGE THROUGHOUT THE OPEN PACK WELL, THE SLIGHT UPWARD DRIFT IN QC WITH THE OPEN PACK SUGGESTS THE POTENTIAL OF A HIGH CONCENTRATION OF ENVIRONMENTAL CO2 ABSORBING INTO THE OPEN PACK. THE CAUSE OF THE EVENT IS ENVIRONMENTAL CO2 ABSORBING INTO THE SAMPLES AND OPEN REAGENT PACK. THE CUSTOMER HAS RUN CO2_C AFTER THIS ISSUE WITH NO PROBLEMS. THE REAGENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    FIVE DISCORDANT, FALSELY ELEVATED CARBON DIOXIDE, CONCENTRATED (CO2_C) RESULTS WERE OBTAINED ON AN ATELLICA CH 930 ANALYZER USING ATELLICA CH CARBON DIOXIDE, CONCENTRATED (CO2_C) REAGENT (LOT NUMBER: 100274). THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLES WERE REPEATED FOR CO2_C, RECOVERING LOWER. THE REPEAT RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED CARBON DIOXIDE, CONCENTRATED (CO2_C) RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624458 ATELLICA CH CARBON DIOXIDE, CONCENTRATED (CO2_C) ATELLICA CH CARBON DIOXIDE, CONCENTRATED (CO2_C) KHS SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA CH CARBON DIOXIDE, CONCENTRATED (CO2_C) 100274 00630414595900

    Patients

    Seq Age Sex Outcome Treatment
    1