BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XN-10

    MDR report key: 6031502 · Received October 14, 2016

    Report

    Report Number
    1000515253-2016-00027
    Event Type
    Injury
    Date Received
    October 14, 2016
    Date of Event
    September 19, 2016
    Report Date
    September 20, 2016
    Manufacturer
    SYSMEX CORPORATION
    Product Code
    GKZ
    PMA / PMN Number
    K112605
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE REPRESENTATIVE (FSR) ARRIVED ONSITE ON SEPTEMBER 20, 2016 TO VERIFY THE OPERATION OF THE ANALYZER. THE FSR CLEANED THE RBC TRANSDUCER ON THE ANALYZER AND CHECKED THE ASPIRATION SENSOR FUNCTIONS. ALL LEVELS OF CUSTOMER QUALITY CONTROL (QC) WERE RUN AND THE RESULTS WERE WITHIN THE CUSTOMER SPECIFIED RANGES. INSTRUMENT TESTED OPERATIONAL. NO ANALYZER MALFUNCTION WAS IDENTIFIED. THE CLSI STANDARD H20-A2 STATES THAT MACROSCOPICALLY VISIBLE CLOTS ARE CAUSE FOR REJECTION OF THE SPECIMEN FOR ANALYSIS. A CLOT IN A SAMPLE CAN BE CAUSED BY A NUMBER OF FACTORS, SUCH AS INADEQUATE MIXING IMMEDIATELY AFTER BLOOD DRAW WHERE THE ANTI-COAGULANT IN THE COLLECTION TUBE IS NOT THOROUGHLY MIXED WITH THE SAMPLE. A CLOTTED SAMPLE IS AN UNACCEPTABLE SPECIMEN FOR HEMATOLOGY TESTING. THE USER IS RESPONSIBLE FOR PROPER COLLECTION OF SAMPLES AND CHECKING THEIR INTEGRITY PRIOR TO ANALYSIS. THE USER DEFINED SETTING FOR IP MESSAGE "THROMBOCYTOPENIA" IS SET AT PLT < 40 X 10³/L. PRODUCT INFORMATION DOCUMENT 63-1034 DATED SEPTEMBER 2012 PROVIDES SYSMEX SUGGESTED SETTINGS FOR ABNORMAL FLAGGING. THIS DOCUMENT RECOMMENDS THE THROMBOCYTOPENIA FLAG IN HOSPITALS TO BE SET FOR REVIEW AT PLT < 100 X 10³/L. HAD THE FLAG BEEN SET AT THESE RECOMMENDATIONS A THROMBOCYTOPENIA FLAG WOULD HAVE TRIGGERED ADVISING THE USER TO REVIEW RESULTS PRIOR TO REPORTING.

    Description of Event or Problem · 1

    THE USER REPORTED THAT AN ERRONEOUSLY LOW PLATELET (PLT) VALUE WAS REPORTED RESULTING IN A DELAYED CAESAREAN SECTION (C-SECTION ) FOR A LABOR AND DELIVERY PATIENT. THE PATIENT'S SAMPLE WAS ANALYZED ON (B)(6) 2016 AT 2:33 AND GENERATED A LOW PLT RESULT OF 88 X 10^3/UL (NORMAL RANGE: 150-350 X 103/UL) . THE PHYSICIAN QUESTIONED THE LOW PLT RESULT FOR THE PATIENT. A NEW SAMPLE WAS COLLECTED AND ANALYZED ON (B)(6) 2016 AT 05:16 AND GENERATED A PLT RESULT OF 202 X 10^3/UL. THE USER LATER CHECKED THE INITIAL SAMPLE AND DISCOVERED A LARGE CLOT. THIS ISSUE WILL BE REPORTED ON THE BASIS A C-SECTION WAS DELAYED 3 HOURS AND 12 MINUTES. A DELAY IN AN C-SECTION CARRIES WITH IT THE RISK OF MATERNAL DEATH, THROMBOEMBOLISM, HEMORRHAGE, INCREASED RISK OF INFECTION, AND FOR THE INFANT THE RISK OF NEONATAL DEATH, FETAL INJURY, RESPIRATORY DIFFICULTIES, AND ASTHMA. THE OPERATOR CONFIRMED THERE WAS NO HARM TO THE MOTHER OR BABY INCURRED AS A RESULT OF THE ERRONEOUS PLT RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681228 XN-10 AUTOMATED HEMATOLOGY ANALYZER GKZ SYSMEX CORPORATION XN-10

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other