BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYSMEX CS-2100I

    MDR report key: 12002069 · Received June 15, 2021

    Report

    Report Number
    1000515253-2021-00010
    Event Type
    Injury
    Date Received
    June 15, 2021
    Date of Event
    May 21, 2021
    Report Date
    June 15, 2021
    Manufacturer
    SYSMEX CORPORATION
    Product Code
    JPA
    PMA / PMN Number
    K162688
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER STATED INITIAL ANALYSIS OF SAMPLE ID (B)(6) WAS ACCOMPANIED BY INSUFFICIENT SAMPLE ERROR CODES. REVIEW OF THE ANALYZER ERROR LOG REVEALS INSUFFICIENT SAMPLE (LIQUID SURFACE NOT DETECTED) ERRORS BEING GENERATED ON 5.15.2021 AT 10:33:56, 22:04:55, 22:38:21 AND ON 5.16.2021 AT 00:32:31, 00:55:07, AND 03:41:58. THE GENERATION OF ERRORS WOULD ALERT THE USER TO AN ISSUE THAT NEEDS TO BE RESOLVED PRIOR TO RESUMING SAMPLE ANALYSIS. THE CS-2000I / CS-2100I INSTRUCTIONS FOR USE (IFU), CHAPTER 8 - TROUBLESHOOTING, DESCRIBES THE INSUFFICIENT SAMPLE (LIQUID SURFACE NOT DETECTED) ERROR AS FOLLOWS: PROBABLE CAUSE: THE SAMPLE VOLUME IS INSUFFICIENT. THE SAMPLE IS NOT SET. THE LIQUID SURFACE SENSOR HAS FAILED. THE ERROR IN SAMPLE ASPIRATION OCCURS DUE TO BUBBLES OR CLOTTING. SOLUTION: SET THE SAMPLE WITH REQUIRED VOLUME AND ANALYZE AGAIN. CHECK THE SAMPLE. THE USER REQUESTED SERVICE TO INSPECT THE ANALYZER. THE SERVICE ENGINEER NOTED BUBBLES IN THE SAMPLE PROBE TUBING AND FOUND THAT THE SAMPLE PROBE TUBING WAS WET. REPLACING THE SAMPLE PROBE TUBING RESOLVED THE ISSUE. THE SUSPECT TUBING WAS NOT AVAILABLE FOR FURTHER INVESTIGATION. ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    A USER IN (B)(6) REPORTED THE PATIENT WAS UNNECESSARILY ADMINISTERED VITAMIN K DUE TO ERRONEOUS HIGH PROTHROMBIN TIME (PT) AND INTERNATIONAL NORMALIZED RATIO (INR) RESULTS. THE SAMPLE WAS ANALYZED, GENERATING AN INSUFFICIENT SAMPLE ERROR AND NO NUMERIC PT/INR RESULTS. THE SAMPLE WAS REANALYZED ON THE SAME ANALYZER AND GENERATED NUMERIC PT/INR RESULTS THAT WERE REPORTED. THE LABORATORY NOTED SEVERAL PATIENT SAMPLES WERE GENERATING HIGHER THAN EXPECTED PT/INR RESULTS. THE SAMPLE WAS REANALYZED ON ANOTHER ANALYZER, WHICH GENERATED LOWER PT/INR RESULTS. A CORRECTED REPORT WAS ISSUED. FIVE DAYS LATER, THE PATIENT RECEIVED VITAMIN K TREATMENT. NO PATIENT HARM DUE TO THE UNNECESSARY TREATMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    898121 SYSMEX CS-2100I AUTOMATED COAGULATION ANALYZER JPA SYSMEX CORPORATION CS-2100I

    Patients

    Seq Age Sex Outcome Treatment
    1 Other