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

Model Number XN-10

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Blood Loss (2597)

Event Date 08/28/2017

Event Type  Injury  

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 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
• Type of Device: AUTOMATED HEMATOLOGY ANALYZER
• Manufacturer (Section D): SYSMEX CORPORATION, I SQUARE; 262-11 mizuashi; noguchi-cho; kakogawa-city, hyogo 675-0 019; JA 675-0019
• Manufacturer (Section G): SYSMEX CORPORATION, I SQUARE; 262-11 mizuashi; noguchi-cho; kakogawa-city, hyogo 675-0 019; JA 675-0019
• Manufacturer Contact: peter shearstone ; 577 aptakisic rd; lincolnshire, IL 60069 ; 2245439514
• MDR Report Key: 6985602
• MDR Text Key: 90506262
• Report Number: 1000515253-2017-00037
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 04987562424221
• UDI-Public: 04987562424221
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: K112605
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 10/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Medical Technologist
• Device Model Number: XN-10
• Device Catalogue Number: AP795756
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other