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

Model Number XN-10

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/18/2019

Event Type  Injury  

Manufacturer Narrative

The initial analysis was judged "negative" with no interpretative program (ip) messages.Any flag not generated indicates the user-defined criteria was not met.The sysmex xn-9000 instructions for use (ifu) - chapter 11 further details ip message types, meanings, and judgment methods, and provides the default ip message settings.The user-defined setting for "thrombocytopenia" was disabled.The default setting for "thrombocytopenia" is a plt value < 60 x 10^3/ul.Had the user followed the manufacturer's recommended default settings, the sample would have been judged "positive" indicating the need for further review of the sample prior to result reporting.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 (b)(6) analyzed a patient sample and an erroneous low platelet (plt) result was generated.The result was reported to the medical team and the patient was transfused with one unit of plts.The patient's blood was drawn post transfusion and the specimen was analyzed.A low plt result was generated, triggered a delta check and the result was held.The operator performed a smear review and plt clumps were observed.Due to the presence of plt clumps on the second sample, the operator suspected the first sample plt result was erroneously low.There was no harm to the patient reported due to the unnecessary plt transfusion.

• Brand Name: SYSMEX XN-10
• Type of Device: AUTOMATED HEMATOLOGY ANALYZER
• Manufacturer (Section D): SYSMEX CORPORATION; 314-2 kitano; noguchi-cho; kakogawa, 675-0 011; JA 675-0011
• Manufacturer (Section G): SYSMEX CORPORATION; 314-2 kitano; noguchi-cho; kakogawa, 675-0 011; JA 675-0011
• Manufacturer Contact: nancy gould ; 577 aptakisic rd; lincolnshire, IL 60069 ; 2245439678
• MDR Report Key: 9532931
• MDR Text Key: 188807010
• Report Number: 1000515253-2019-00025
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 04987562424214
• UDI-Public: (01)04987562424214
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K112605
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• 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: 12/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/10/2013
• 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
• Patient Age: 61 YR