MAUDE Adverse Event Report: SYSMEX CORPORATION SYSMEX XN-20 ANALYZER; AUTOMATED HEMATOLOGY ANALYZER

Model Number XN-20

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

Patient Problem Cancer (3262)

Event Date 11/14/2014

Event Type  Injury  

Event Description

Sysmex corporation (s-corp) was contacted by a user from (b)(6) regarding an incident of unnecessary chemotherapy after the xn-20 generated a falsely elevated eosinophil count.A sample from cancer patient was analyzed on (b)(6) at 16:01 for a cbc+diff+nrbc.The sample was judged "positive" with multiple interpretive program (ip) messages.The eosinophil (eos) value generated by the analyzer was elected.The result was reported.The operator performed repeat analysis.The sample was judged "negative" with no ip message flags.The eos value generated by the analyzer was within normal range.The sample was repeated several more times with similar results.The operator performed a manual differential to verify accurate results, data was not provided.Erroneous results were reported.The pt was given a tablet of chemotherapy, titanium silicate (ts)-1, used in (b)(6) for the treatment of gastric cancer.The chemotherapy was administered due to the erroneous results generated.No report of adverse reaction or serious deterioration of health was reported.

Manufacturer Narrative

This event is being reported on the basis that incorrect results led to a pt receiving unnecessary chemotherapy treatment.Xn-900 automated hematology analyser system consists of four xn-20 analyzers (serial numbers (b)(4)).The analyzers to which the serial numbers correspond were not identified.The narrative identified the analyzers as xn-9000-1 through xn-9000-4.The analyzer alerted the operator to possible sample abnormality on initial analysis.The sample was judged "positive" with ip messages indicating possible sample abnormality.Some parameters were accompanied with an asterisk, "*," indicating the data is unreliable due to possible interference.These indicators alert the operator that further verification of accurate results prior to reporting is required.The generation of erroneous results is likely due to a sample specific issue, subsequent analyses of the sample generated accurate results.The event is due to usee error analyzer performed as designed.

• Brand Name: SYSMEX XN-20 ANALYZER
• Type of Device: AUTOMATED HEMATOLOGY ANALYZER
• Manufacturer (Section D): SYSMEX CORPORATION; kakogawa ; JA
• Manufacturer (Section G): SYSMEX CORPORATION; 314-2 kitano; noguchicho kak0gawa 675- 0011; JA 675-0011
• Manufacturer Contact: peter shearstone, vp ; 577 aptakisic rd; lincolnshire, IL 60069 ; 2245439515
• MDR Report Key: 4380267
• MDR Text Key: 5114404
• Report Number: 3009711478-2014-00026
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K112605
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 12/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: XN-20
• Device Catalogue Number: AE797961
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/16/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other