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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial analysis was judged "negative".The sysmex xn-3000 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 user-defined.The system bases judgments on comprehensive surveys of numerical data, particle-size distributions, and scattergrams.Flags and messages, communicated through interpretive program (ip) messages, indicate the analyzer's findings and notify the user of possible sample specific abnormalities.User-defined settings will impact sample judgement and generation of flags.Chapter 11 - checking detailed analysis information (data browser), section 11.6.1 - ip message judgment conditions and judgment methods discusses the manufacturer recommended settings for the anemia flag, which is a hgb <10.0 g/dl.Initial analysis generated a hgb value <10.0 g/dl.The analyzer ip message setting for the anemia flag was unknown at the time of assessment.Had the anemia flag been set to the manufacturer recommended settings prior to initial analysis, the analyzer would have alerted the operator to further verification.The operator stated the original sample volume was approximately 1.5ml.Chapter 9 - analyzing samples, indicates required sample volume for whole blood in automated mode as 1ml.Chapter 14 - troubleshooting states the following for the 'insufficient blood volume (short sample)' error message: probable cause: 'low hemoglobin value,' action: check the blood volume and whether the blood has coagulated, and click [accept] in the help dialog box.If the blood volume is sufficient and there is no coagulation, a low hemoglobin value is possible.Disable the blood aspiration sensor and repeat analysis using manual analysis.The operator indicated there was no coagulation observed in the original sample.No evidence was provided that demonstrates the operator performed the action of disabling the blood aspiration sensor and performing repeat analysis as instructed through troubleshooting.No systemic analyzer deficiency was identified.
Event or Problem Description
The sample was analyzed twice and generated short sample errors.Upon the third analysis, a critically low hemoglobin (hgb) result of 3.3 g/dl was generated.The operator stated sample volume was sufficient with approximately 1.5ml.A transfusion of one unit of packed red blood cells (prbc) was administered based on the low hgb result.No negative patient impact from the transfusion was reported.A new sample was collected from the patient after transfusion which generated a hgb result of 10.3 g/dl.The result was inconsistent with expected results post-transfusion (1-2 g/dl increase in hgb per unit of prbc).Another sample was collected the following day which generated a hgb result of 9.7 g/dl.The operator suspects the hgb results of the original sample were erroneous, which contributed to an unnecessary transfusion.

• 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: 12343082
• Report Number: 1000515253-2021-00014
• Device Sequence Number: 4115272
• Product Code: GKZ
• UDI-Device Identifier: 04987562424214
• UDI-Public: (01)04987562424214(11)170810
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 08/19/2021

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: 08/11/2021
• Initial Report FDA Received Date: 08/19/2021
• 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: 71 YR
• Patient Weight: 48