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

Model Number	XN-20
Medical Device Problem Codes	Fluid/Blood Leak (1250); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The analysis of sample id (b)(6) was judged "positive" with an interpretive program (ip) message, alerting the user to possible sample abnormality.The sysmex xn-9000/xn-91000 instruction for use (ifu), chapter 11 - checking detailed analysis information (data browser), section 11.5 - ip message cautions: "a "positive' or "error' judgment indicates the possibility of an abnormality.If a "positive' or "error' judgment occurs, check the data and repeat the test or examine carefully in accordance with the protocol of your laboratory." the analysis generated a hct result that was inconsistent with the hgb result and mch and mchc results were abnormally low.Abnormal indices can indicate performance problems in hematology analyzers as well as specimen or patient abnormalities.Review of the analyzer error log indicates the analyzer generated multiple x-barm control errors, starting prior to sample analysis.The user contacted roche (b)(4) (distributor) the morning after sample analysis to report no results for multiple parameters were generated during quality control (qc) analysis.A roche service engineer (se) was dispatched and identified a leaking valve assy.No.23.The se replaced the suspect valve assy.No.23 to resolve the issue.Part replacement was performed as part of routine servicing due to the extended age and use of the analyzer.
Event or Problem Description
A patient in (b)(6) underwent an unnecessary endoscopy procedure based on an erroneous low hemoglobin (hgb) result generated by the analyzer.There was no harm reported due to the unnecessary endoscopy.

• Brand Name: SYSMEX XN-20
• 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: 11345421
• Report Number: 1000515253-2021-00003
• Device Sequence Number: 19767459
• Product Code: GKZ
• UDI-Device Identifier: 04987562424221
• UDI-Public: (01)04987562424221(11)180124
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K112605
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/18/2021

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: Health Professional
• Device Model Number: XN-20
• Device Catalogue Number: AE797961
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2021
• Initial Report FDA Received Date: 02/18/2021
• 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