MAUDE Adverse Event Report: SYSMEX CORPORATION, I SQUARE SYSMEX XN-10; AUTOMATED HEMATOLOGY ANALYZER

Model Number XN-10 COMPLETE

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 07/01/2019

Event Type  Injury  

Manufacturer Narrative

The operator stated a delta check on the initial analysis was generated.The purpose of delta checking is to judge if the data is abnormal or not based on the variation between the latest data and the previously analyzed data.It is the responsibility of the user to verify delta flagging prior to result reporting.The user-defined setting for "thrombocytopenia" was not provided.The sysmex xn-9000 instructions for use (ifu), chapter 11- checking detailed analysis information (data browser), further details ip message types, meanings, and judgment methods, and provides the default ip message settings.The default setting for "thrombocytopenia" is a plt value of < 60 x 10^3/ul.Chapter 15: technical information, section 15.2 - system limitations and interfering substances, informs of situations where results may be affected.For plts, the ifu states: "if any of the following are present, the system may erroneously report a low plt count: possibility of plt clumps, pseudothrombocytopenia (caused by edta typically), giant plt." the operator reported that plt clumps were present.Plt clumps can be caused by abnormal proteins in the patient's plasma that cause plt to clump when exposed to edta anti-coagulant.The longer a sample is exposed to edta, more clumping that can occur.No analyzer deficiency was identified.

Event Description

An operator in korea analyzed a patient sample which generated an erroneous low patient platelet (plt) value.The analysis generated a delta check and a critical low plt message.No objective evidence was provided.The plt result was released to the medical team and the patient received an unnecessary transfusion of plt concentrates.No patient harm was reported due to the plt transfusion.The operator reported that plt clumps were present in the sample.

Manufacturer Narrative

This event was initially reported as a mdr with the preliminary information provided.After additional information confirmed there was no evidence of plt transfusion or patient harm.Both analyses of sid (b)(6) were judged "positive" with ip messages alerting the user to sample abnormality.The sysmex xn-9000 ifu, chapter 11 - checking detailed analysis information (data browser), section 11.5 - ip messages, details the method in which the analyzer conveys its findings.Results without an error message are categorized as "positive" or "negative" based upon preset criteria, some of which are laboratory-defined.The system bases judgments on comprehensive surveys of numerical data, particle-size distributions, and scattergrams.Flags and messages, communicated through ip messages, indicate the analyzer's findings and notify of possible sample specific abnormalities.Further verification of accurate results is recommended prior to reporting to the clinician.The repeat analysis for sid (b)(6) generated results with an asterisk.The sysmex xn-9000 instructions for use (ifu), chapter 10 - checking analysis data (sample explorer), section 10.1.4 - numerical data of the analysis results, describes the masks and marks that may be added to analysis data.Masks and marks indicate an abnormality in the analysis data.An asterisk [*] indicates the data is unreliable.The root cause of this issue is undetermined, however the data suggest a patient specific abnormality contributed to the event.The analyzer performed as designed by alerting the operator to a possible sample abnormality.

Event Description

On 10/28/2019 sysmex korea provided additional information.An operator in korea analyzed a patient sample which generated an erroneous low platelet (plt) value.The plt result was reported to the medical team.The doctor requested that the operator confirm the plt result.The sample was reanalyzed.The plt result was near the normal reference range and a corrected reported was issued.It was previously reported that the patient received an unnecessary plt concentrate transfusion.It was later confirmed there was no plt transfusion administered.No negative impact to patient management.

• Brand Name: SYSMEX XN-10
• Type of Device: AUTOMATED HEMATOLOGY ANALYZER
• Manufacturer (Section D): SYSMEX CORPORATION, I SQUARE; 262-11 mizuashi; noguchi-cho; kakogawa-city, 675-0 019; JA 675-0019
• MDR Report Key: 9180687
• MDR Text Key: 173208816
• Report Number: 1000515253-2019-00018
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 04987562424214
• UDI-Public: (01)04987562424214(11)181217
• Combination Product (y/n): N
• PMA/PMN Number: K112605
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 10/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: XN-10 COMPLETE
• Device Catalogue Number: AP795756
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/11/2019
• Initial Date FDA Received: 10/11/2019
• Supplement Dates Manufacturer Received: 10/28/2019
• Supplement Dates FDA Received: 10/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 64 YR