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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/23/2020

Event Type  Injury  

Manufacturer Narrative

The laboratory recently started reporting body fluids, and there was confusion in the laboratory regarding the xn units versus the lis units for the red blood cell body fluid (rbc-bf) parameter.The xn units were displayed as 10^3/ul, while the lis units were displayed as k/ul.Due to the unit difference, the laboratory adopted a manual process for reporting body fluid results for both the wbc-bf and rbc-bf parameters.During this manual entry process, the transcription error for the wbc-bf parameter occurred.The rbc-bf parameter was reported correctly.To resolve the issue, the laboratory changed the rbc-bf units on the xn analyzer.No analyzer deficiency was identified.

Event Description

A patient underwent an unnecessary exploratory knee arthroscopy procedure due to an erroneously high white blood cell body fluid (wbc-bf) result.The patient's synovial fluid was analyzed on a hematology analyzer, and the analyzer generated an accurate result.The user manually entered the wbc-bf result in the laboratory information system (lis).When the user manually entered the result, the user unintentionally reported a value that was approximately 10 times greater than the actual result.The falsely increased wbc-bf result led to the unnecessary procedure.No patient harm was incurred due to the procedure.

• 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: nancy gould ; 577 aptakisic rd; lincolnshire, IL 60069 ; 2245439678
• MDR Report Key: 10906245
• MDR Text Key: 218911221
• Report Number: 1000515253-2020-00030
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 04987562424214
• UDI-Public: (01)04987562424214(11)170315
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112605
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: XN-10
• Device Catalogue Number: AP795756
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/01/2017
• 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