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

Model Number	XN-10
Medical Device Problem Codes	Mechanical Problem (1384); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The analysis of sample (b)(6) was judged "positive" with interpretive program (ip) messages, alerting the user to possible sample abnormality.The sysmex xn-9000/xn-9100 instruction for use (ifu), chapter 11 - checking detailed analysis information (data browser), section 11.5 - ip messages, 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 hematocrit (hct) result that was inconsistent with the hgb result, mean corpuscular hemoglobin (mch) and mean corpuscular hemoglobin concentration (mchc) results were abnormally low.Abnormal indices and the usual relationship between hgb/hct (mchc) may indicate performance problems in hematology analyzers, as well as specimen or patient abnormalities.The user contacted the sysmex technical assistance center (tac) after troubleshooting for increased delta checks had generated quality control (qc) failures.A service engineer (se) was dispatched and identified failure of master valve (mv) 59.The se replaced the suspect mv 59 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
The patient was administered an unnecessary packed red blood cell (prbc) transfusion due to an erroneous low hemoglobin (hgb) result generated by the analyzer.The transfusion was stopped after an accurate hgb result from repeat analysis on another analyzer was provided to the clinician.No adverse effects from the transfusion were reported.

• 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: 11565574
• Report Number: 1000515253-2021-00005
• Device Sequence Number: 2955111
• Product Code: GKZ
• UDI-Device Identifier: 04987562424214
• UDI-Public: (01)04987562424214(11)190517
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K112605
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 03/24/2021

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-10
• Device Catalogue Number: AP795756
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2021
• Initial Report FDA Received Date: 03/24/2021
• 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
• Patient Age: 78 YR
• Patient Weight: 54