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

Model Number	XN-10
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	08/28/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The use of fine gauge needles during collection may cause damage to the blood cells.The laboratory performed a study using fine gauged needles and confirmed that an increased plt value was generated when using this collection technique.According to the sysmex analyzer instructions for use, "if any of the following is present, the system may erroneously report a high platelet count: microerythrocytes, possibility of fragmented rbcs, fragmented leukocytes." a roche field service engineer was dispatched to verify analyzer performance.The se performed routine maintenance and determined that the analyzer performed within specification.No analyzer deficiency was identified.
Event or Problem Description
The sample was collected using a syringe and fine gauge needle.Analysis was performed on (b)(6) 2017, time unknown, and the user stated that a plt value of 70 x 10^9/l was reported to the clinician.A bone marrow aspiration procedure was performed.The reason for the procedure was not provided.It was reported that the patient bled more than normal during the procedure.The clinician requested a repeat analysis, which generated a plt value of 5 x 10^9/l.No other patient information was provided.

• Brand Name: XN-10
• Common Device Name: AUTOMATED HEMATOLOGY ANALYZER
• Manufacturer (Section D): SYSMEX CORPORATION, I SQUARE; 262-11 mizuashi; noguchi-cho; kakogawa-city, hyogo 675-0 019; JA 675-0019
• MDR Report Key: 6985602
• Report Number: 1000515253-2017-00037
• Device Sequence Number: 11069687
• Product Code: GKZ
• UDI-Device Identifier: 04987562424221
• UDI-Public: 04987562424221
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K112605
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 10/27/2017

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: Medical Technologist
• Device Model Number: XN-10
• Device Catalogue Number: AP795756
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2017
• Initial Report FDA Received Date: 10/27/2017
• 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