MAUDE Adverse Event Report: SYSMEX CORPORATION, I SQUARE 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	02/22/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
All analyses of the suspect sample were analyzed in the manual mode.Chapter 9 - analyzing samples, section 9.2.1 - sample types and handling, cautions users to ensure samples are sufficiently mixed prior to analysis.A delay in processing after mixing can lead to the production of erroneous results.In this mode, the sample must be mixed by gentle inversion ten times prior to introducing the sample to the instrument for analysis.When samples are inadequately mixed, red blood cells settle to the bottom of the sample, causing falsely increased hgb results.It is the responsibility of the user to mix samples appropriately prior to patient analysis.All analyses of the suspect sample were judged "positive" with ip messages.The sysmex xn-3000/xn-3100 instructions for use (ifu), chapter 11 - checking detailed analysis information (data browser), section 11.6 - ip messages, details the method in which the analyzer conveys its findings.Results without an error message are categorized as "positive" or "negative" based upon preset criteria, some of which are laboratory-defined.The system bases judgments on comprehensive surveys of numerical data, particle-size distributions, and scattergrams.Flags and messages, communicated through ip messages, indicate the analyzer's findings and notify of possible sample specific abnormalities.Further verification of accurate results is recommended prior to reporting to the clinician.Wam data was reviewed.It was determined the wam rule triggered appropriately and auto validated the suspect hgb result per user-defined criteria.The wam rule that triggered on the suspect sample did not include holding the hgb result for the delta check.Users are responsible for testing all rules to ensure the rule works as intended prior to implementation.The analyzer and wam performed as designed.
Event or Problem Description
The user alleged a transfusion was delayed approximately 4 hours due to an erroneously high hemoglobin (hgb) result.The suspect patient sample was analyzed in the manual mode generating a high hgb result with an interpretive program (ip) message, alerting the user to sample abnormality.The suspect hgb result was transmitted to work area manager (wam) middleware.A wam rule triggered based on the ordering criteria and auto validated the suspect hgb result to the laboratory information system (lis).The suspect hgb result was highlighted in wam, indicating the hgb result failed a delta check, because the previous sample for this patient had a low hgb result.The user was unaware of the delta check due to auto validation of the suspect sample.A new sample was drawn approximately 4 hours later.The new sample was analyzed, generating a critically low hgb result.When the user called the critically low hgb result, the nurse questioned the suspect hgb result.The user reanalyzed the suspect sample, which generated a critically low hgb result.There was no report of harm to the patient due to the transfusion delay.

• Brand Name: SYSMEX XN-10
• 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: 9849958
• Report Number: 1000515253-2020-00013
• Device Sequence Number: 11505102
• Product Code: GKZ
• UDI-Device Identifier: 04987562424214
• UDI-Public: (01)04987562424214(11)190401
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K112605
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/18/2020

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: 03/06/2020
• Initial Report FDA Received Date: 03/18/2020
• 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: 44 YR