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

Model Number	XN-10
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The initial sample was judged "positive" with multiple interpretive program (ip) messages generated.The sysmex xn-1000 instructions for use (ifu), chapter 11 - checking detailed analysis information (data browser), section 11.6 - ip messages states that all analyzed samples without analysis errors can be separated into a "positive" or "negative" category according to preset criteria, some of which are user-defined.The system bases its judgments on comprehensive surveys of numerical data, particle-size distributions, and scattergrams.Flags and messages, referred to as ip messages, indicate the analyzer's findings.The purpose of ip message flagging is to alert the operator to possible sample abnormality.Abnormal results require verification, either by repeating on the same or another analyzer in accordance with laboratory protocol.The analyzer alerted the operator to possible sample abnormality requiring verification prior to reporting of results.The user did not verify accurate results prior to reporting to the clinician.Based on the information provided, root cause of falsely decreased hgb result is undetermined, however the analyzer alerted the operator to possible sample abnormality.Quality control was within specification.A pre-analytical error such as sample handling/storage could not be ruled out as a contributing factor.User error did contribute to this event.The initial user did not verify accurate results prior to reporting to the clinician.The second user had verified a higher hgb result approximately 18 hours prior to the administration of the rbc transfusion, and did not notify the clinician nor generate corrected reports.
Event or Problem Description
An operator in (b)(6) analyzed the patient sample and a falsely low hemoglobin (hgb) result was generated.The sample was judged positive with several flags alerting the operator to possible sample abnormality.The operator reported the low hgb value to the clinician, without further verification of accurate results.The sample was sent to another lab for crossmatch and repeat testing.Reanalysis generated a higher hgb value, the clinician was not notified of the change in hgb value and no corrected reports were issued.The patient was transfused with two units of packed red blood cells (rbcs).The clinician was notified of the higher hgb result after the patient had been transfused.This event is reportable to the fda as an unnecessary rbc transfusion was administered to the patient due to a falsely decreased hgb result.No patient harm was reported based on the transfusion.

• Brand Name: SYSMEX XN-10
• Common Device Name: SYSMEX XN-10 AUTOMATED HEMATOLOGY ANALYZER
• Manufacturer (Section D): SYSMEX CORPORATION, I SQUARE; 262-11 mizuashi; noguchi-cho; kakogawa-city, 675-0 019; JA 675-0019
• MDR Report Key: 8649983
• Report Number: 1000515253-2019-00013
• Device Sequence Number: 284525
• Product Code: GKZ
• UDI-Device Identifier: 04987562424214
• UDI-Public: (01)04987562424214
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K112605
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/29/2019

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-10
• Device Catalogue Number: AP795756
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2019
• Initial Report FDA Received Date: 05/29/2019
• 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
• Patient Age: 72 YR