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

Model Number	XN-10 COMPLETE
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The initial analysis of sid (b)(6) was judged "positive" with interpretive program (ip) message "thrombocytopenia" alerting to sample abnormality.The sysmex xn-3000 instructions for use (ifu), chapter 11 - checking detailed analysis information (data browser), section 11.6 - 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.Chapter 15 - technical information, section 15.2 - system limitations and interfering substances, informs of situations where results may be affected.For plts, the ifu notes: "if any of the following are present, the system may erroneously report a low platelet count: possibility of plt clumps, pseudothrombocytopenia (caused by edta typically), giant platelets." plt clumping was noted upon smear review.Plt clumps can be caused by abnormal proteins in the patient's plasma that cause plts to clump when exposed to edta anticoagulant.The longer a sample is exposed to edta, more clumping can occur.When the sample with sodium citrate anticoagulant was analyzed, the analyzer generated a higher plt result as compared to the edta sample.The higher plt result generated from the sodium citrate anticoagulant sample supports the possibility of edta induced pseudothrombocytopenia.The investigation determined the analyzer performed as designed.
Event or Problem Description
The sample was analyzed and generated a false low platelet (plt) result.The analyzer generated a "thrombocytopenia" flag alerting the user to verify results.A smear was reviewed and clumps of 2-3 plts per every few high-powered fields were noted.A plt estimate was not performed.The complete blood cell count (cbc) results were released to the laboratory information system (lis).Two units of plts were ordered and transfused.A post transfusion sample was analyzed and a normal plt result was generated.A pre-transfusion sodium citrate sample was analyzed and a normal plt result was generated.No corrected report was issued.The patient received two unnecessary plt transfusions due to the erroneous low plt result.No patient harm incurred from the transfusions.

• Brand Name: SYSMEX XN-10
• Common Device Name: 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: 8896949
• Report Number: 1000515253-2019-00017
• Device Sequence Number: 419759
• Product Code: GKZ
• UDI-Device Identifier: 04987562424214
• UDI-Public: (01)04987562424214(11)160623
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K112605
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/15/2019

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
• Operator of Device: Health Professional
• Device Model Number: XN-10 COMPLETE
• Device Catalogue Number: AP795756
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2019
• Initial Report FDA Received Date: 08/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 50 YR
• Patient Weight: 87