BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYSMEX XE-2100 AUTOMATED HEMATOLOGY ANALYZER

    MDR report key: 2687226 · Received August 18, 2011

    Report

    Report Number
    1422681-2011-00003
    Event Type
    Other
    Date Received
    August 18, 2011
    Date of Event
    July 3, 2011
    Report Date
    July 3, 2011
    Manufacturer
    SYSMEX CORPORATION
    Product Code
    GKZ
    PMA / PMN Number
    K040073
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYSMEX WAM SUPPORT REMOTELY LOGGED INTO THE CUSTOMER'S WAM TO PERFORM INVESTIGATION. ROOT CAUSE WAS DETERMINED TO BE THE LABORATORY INFORMATION SYSTEM (LIS) AT THE CUSTOMER SITE DID NOT SEND THE COLLECTION DATE/TIME TO WAM. WITHOUT THE COLLECTION DATE/TIME, THE WAM WILL ATTEMPT TO USE THE RECEIVED DATE/TIME TO DETERMINE THE MOST RECENT PREVIOUS SAMPLE. WHEN ORDERS ARE RECEIVED FROM THE LIS, IF NO OTHER DATE AND TIME IS PROVIDED, WAM DEFAULTS THE DATE/TIME OF ORDER RECEIPT INTO THE RECEIVED DATE/TIME SLOT. THIS CAN BE UPDATED WHEN THE SAMPLE IS RECEIVED IN THE LABORATORY. IN THIS INSTANCE, THE RECEIVED DATE/TIME WAS NEVER UPDATED BY THE CUSTOMER WHEN THE SAMPLE WAS RECEIVED IN THE LABORATORY. BECAUSE 3 SAMPLES WERE ORDERED AT THE SAME TIME, THE DEFAULTED SAMPLE RECEIVED DATES/TIMES WERE IDENTICAL. WITH IDENTICAL DATES/TIMES, THE WAM CANNOT DETERMINE THE ORDER OF SAMPLES. THE MOST RECENT PREVIOUS DIFFERENT SAMPLE, (B)(4), WAS USED FOR THE DELTA CHECK. BECAUSE THE 10.1 G/DL HGB RESULT FROM (B)(4) WAS NOT GREATER THAN +/- 2G/DL FROM THE 8.5 G/DL HGB, NO DELTA CHECK WAS TRIGGERED. IN THIS CASE, THE WAM PERFORMED AS DESIGNED WITH THE INFORMATION PROVIDED. IT WAS DETERMINED THE LABELING FOR THIS DEVICE COULD BE MORE SPECIFIC AND INCLUDE DIRECTION SURROUNDING THE COLLECTION DATE AND TIME IN RELATION TO THE DELTA CHECK FUNCTION. THIS HAS BEEN RESOLVED IN THE MOST CURRENT VERSION OF THE WAM SOFTWARE (4.1) AND A CAPA HAS BEEN OPENED TO FURTHER INVESTIGATE THE ISSUE AND DETERMINE THE APPROPRIATE ACTION. THERE WAS NO REPORTED ADVERSE EVENT TO THE PATIENT AS A RESULT OF THE BLOOD TRANSFUSION RECEIVED. SYSMEX IS REPORTING THIS EVENT TO THE FDA TO THE INHERENT RISK TO A PATIENT AS A RESULT OF A TRANSFUSION. SOME OF THE POTENTIAL ADVERSE OUTCOMES ARE NOT IMMEDIATELY EVIDENT.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO SYSMEX ON (B)(4) 2011, THAT WHILE USING SYSMEX XE-2100 AUTOMATED HEMATOLOGY ANALYZER WITH THE ACCESSORY, SYSMEX WORK AREA MANAGEMENT (WAM) VERSION 2.0 MIDDLEWARE, A HEMOGLOBIN (HGB) RESULT WAS NOT FLAGGED FOR DELTA FAILURE AND INSTEAD AUTO-VALIDATED. THE CUSTOMER QUESTIONED WHY SAMPLE ID (SID) (B)(4) DID NOT FAIL THEIR HGB DELTA CHECK RULE IN WAM (RULE RBC019) WHICH STATES IF HGB RESULTS DIFFER MORE THAN +/-2 G/DL WITHIN A 3 DAY TIME PERIOD, HOLD THE COMPLETE BLOOD COUNT (CBC) AND AUTOMATIC DIFFERENTIAL (ADIF) RESULTS, ADD A MANUAL REVIEW ORDER, AND RERUN THE SAMPLE FOR CBC. THE PATIENT IS A (B)(6) MALE ADMITTED FOR GASTROINTESTINAL BLEEDING. IT WAS REPORTED HE RECEIVED A BLOOD TRANSFUSION (ONE UNIT) AT AN UNSPECIFIED TIME BASED ON A LOW HGB RESULT AND OTHER CLINICAL SIGNS AND SYMPTOMS ON (B)(6) 2011. SUBSEQUENTLY, THE PATIENT'S HGB LEVEL, HEMATOCRIT (HCT), AND CBC WERE MONITORED. SID (B)(4) RESULTED ON (B)(6) 2011 AT 00:38 WITH A HGB VALUE OF 8.5 G/DL. IT WAS REPORTED TO SYSMEX THAT THE PATIENT RECEIVED A SECOND TRANSFUSION BASED ON THE 8.5 G/DL RESULT RECEIVED. THE PREVIOUS HGB RESULT FOR THIS PATIENT HAD BEEN 11.1 G/DL AND THE CUSTOMER QUESTIONED WHY A HGB DELTA CHECK HAD NOT TRIGGERED. THE SUBSEQUENT ACTIONS TRIGGERED BY THE RULE THEREFORE DID NOT OCCUR (HOLD THE COMPLETE BLOOD COUNT (CBC) AND AUTOMATIC DIFFERENTIAL (ADIF) RESULTS, ADD A MANUAL REVIEW ORDER, AND RERUN THE SAMPLE FOR CBC). THE TECHNICIAN REPORTED THE SAMPLE WAS INCORRECTLY DRAWN FROM ABOVE AN IV LINE, COMPROMISING SPECIMEN INTEGRITY AND RENDERING ALL RESULTS INVALID. THIS CUSTOMER FAILED TO FOLLOW APPROPRIATE LABORATORY PRACTICES IN OBTAINING THE SAMPLE AND REVIEWING SUBSEQUENT RESULTS. THIS WAS NOT DETERMINED UNTIL AFTER THE PATIENT HAD BEEN TRANSFUSED WITH A SECOND UNIT OF BLOOD DUE TO THE LOW HGB RESULT. THE CUSTOMER STATED IF THE DELTA CHECK HAD FLAGGED THE LOW HGB RESULT, THE LABORATORY TECHNICIAN COULD HAVE INQUIRED AS TO HOW THE SAMPLE WAS DRAWN PRIOR TO THE PATIENT RECEIVING THE TRANSFUSION. THE CUSTOMER IS NOT AWARE OF ANY HARMFUL EFFECTS TO THE PATIENT DUE TO THE BLOOD TRANSFUSIONS RECEIVED. NO TRANSFUSION REACTION OCCURRED AND THE PATIENT WAS SUBSEQUENTLY RELEASED FROM THE HOSPITAL. BECAUSE A PATIENT WAS POTENTIALLY UNNECESSARILY TRANSFUSED AND THE CUSTOMER ALLEGES THIS WAS DUE, IN PART, TO THE DELTA CHECK RULE TRIGGERING ON THE LOW HGB RESULT RECEIVED, THIS EVENT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYSMEX XE-2100 AUTOMATED HEMATOLOGY ANALYZER AUTOMATED DIFFERENTIAL CELL COUNTER GKZ SYSMEX CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other INFORMATION TECHNOLOGY SOFTWARE VERSION 2.0| SYSMEX WORK AREA MANAGEMENT (WAM) HEALTH| SERIAL NUMBER (B)(4)