BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XN-10

    MDR report key: 7080998 · Received December 4, 2017

    Report

    Report Number
    1000515253-2017-00042
    Event Type
    Injury
    Date Received
    December 4, 2017
    Date of Event
    November 7, 2017
    Report Date
    December 4, 2017
    Manufacturer
    SYSMEX CORPORATION, I SQUARE
    Product Code
    GKZ
    UDI-DI
    04987562424214
    PMA / PMN Number
    K112605
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT IS EQUIPPED WITH A BLOOD ASPIRATION SENSOR THAT USES THE HGB TO DETECT INSUFFICIENT SAMPLE. THE INSTRUCTIONS FOR USE ADVISES THE USER MAY DISABLE THE BLOOD ASPIRATION SENSOR IF THE "INSUFFICIENT BLOOD VOLUME (SHORT SAMPLE)" FUNCTION ERROR IS GENERATED AND THE SAMPLE MAY HAVE A VERY LOW HGB. DISABLING THE SENSOR TEMPORARILY PREVENTS THE SUPPRESSION OF RESULTS FROM SAMPLES WITH VERY LOW HGB SO A VALUE CAN BE OBTAINED. IT WAS DETERMINED THAT THE INSTRUMENT PERFORMED AS DESIGNED.

    Description of Event or Problem · 1

    THE SAMPLE FROM AN OUTPATIENT WAS ANALYZED FOR HEMOGLOBIN (HGB) AND HEMATOCRIT (HCT) AND AN "INSUFFICIENT BLOOD VOLUME (SHORT SAMPLE)" FUNCTION ERROR OCCURRED. ALL RESULTS WERE DISPLAYED AS DASHES (---), INDICATING MEASUREMENT WAS NOT POSSIBLE. THE SAMPLE WAS REPEATED SEVERAL TIMES GENERATING THE SAME ERROR AND SUPPRESSED RESULTS. THE USER DID NOT PERFORM THE RECOMMENDED TROUBLESHOOTING IN THE INSTRUCTIONS FOR USE (IFU) MANUAL AND DID NOT CALL SYSMEX FOR ASSISTANCE. THE SAMPLE WAS CANCELLED BY THE EVENING SHIFT SUPERVISOR AS "UNABLE TO ANALYZE" AFTER NO RESULTS WERE OBTAINED. THE PATIENT WAS SCHEDULED FOR SAMPLE RECOLLECTION THE FOLLOWING DAY. THE USER CONTACTED SYSMEX ON (B)(6) 2017 AND WAS ADVISED TO TEMPORARILY DISABLE THE BLOOD ASPIRATION SENSOR WHICH SUPPRESSES VERY LOW HGB AND HCT VALUES THAT CAUSE "INSUFFICIENT BLOOD VOLUME (SHORT SAMPLE)" ERROR. THE ORIGINAL SAMPLE WAS ANALYZED TWICE AND A HGB OF 3.8 G/DL WAS OBTAINED FOR BOTH ANALYSES. THE RECOLLECTED SAMPLE GENERATED A HGB OF 3.2 G/DL. THE PATIENT WAS TRANSFUSED WITH FOUR UNITS OF PACKED RED BLOOD CELLS ON (B)(6) 2017 BEGINNING AT 12:39 WITH THE LAST UNIT ADMINISTERED AT 22:35 THE SAME DAY. THE USER STATED THAT THE DELAY OF RESULTS CONTRIBUTED TO AN 18 HOUR DELAY OF NECESSARY TREATMENT TO THE PATIENT. NO HARM TO THE PATIENT WAS REPORTED DUE TO THE DELAY OF TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    858092 XN-10 AUTOMATED HEMATOLOGY ANALYZER GKZ SYSMEX CORPORATION, I SQUARE XN-10 04987562424214

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other