MAUDE Adverse Event Report: SYSMEX CORPORATION 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	11/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The sysmex xn-10 series instructions for use (ifu), chapter 15 - technical information, section 15.2 - system limitations and interfering substances, informs of situations where results may be affected.For plts, the ifu states: "if any of the following are present, the system may erroneously report a low plt count: possibility of plt clumps, pseudothrombocytopenia (caused by edta typically), giant plt." the operator reported that plt clumps were present upon manual smear review.Plt clumps can be caused by abnormal proteins in the patient's plasma that cause plt to clump when exposed to edta anti-coagulant.The longer a sample is exposed to edta, the more clumping can occur.Both initial analyses for the first two samples were judged "positive" with interpretive program (ip) message generated.Results without error messages are classified as "positive" or "negative" based on preset criteria some of which are user defined.Chapter 11 - checking detailed analysis information, section 11.6 - ip messages, state: a "positive" judgment indicates the possibility of an abnormality.The system bases its judgment on comprehensive surveys of numerical data, particle-size distributions, and scattergrams to provide indications of the instrument's findings through ip messages.The analyzer alerted the operator to possible sample abnormality requiring verification.No product malfunction was identified that would pose a risk for serious injury or expectation of recurrence.Well documented pre-analytical conditions like platelet clumping, short samples and fibrin clots contribute to the falsely low platelet counts.The user is responsible for ensuring proper sample integrity prior to analysis, for establishing settings to identify sample abnormalities, and confirming data prior to reporting.
Event or Problem Description
The sample, collected in edta, was analyzed and generated a falsely decreased platelet (plt) value.The sample was repeated with the same low plt value and was reported to the clinician with a comment that this result was not yet verified by manual smear review.A manual smear review confirmed the presence of plt clumps.A new sample, collected in edta, was analyzed a few hours later and generated the same low plt value.A manual smear review confirmed the presence of plt clumps.New samples in an edta tube and a sodium citrate tube were collected from the patient.The edta sample generated a low plt result and the sodium citrate tube generated a normal plt result.Manual smears were performed on both samples which revealed the presence of plt clumps.The results of the manual smear reviews, which included the presence of plt clumps, were reported to the clinician.The user stated the clinician decided to perform a cesarean section using general anesthesia instead of epidural after the initial falsely decreased plt result was reported, even though the procedure was performed after the correct results were reported to the clinician.No harm to the patient or the baby was reported.

• Brand Name: XN-10
• Common Device Name: AUTOMATED HEMATOLOGY ANALYZER
• Manufacturer (Section D): SYSMEX CORPORATION; 314-2 kitano; noguchi-cho; kakogawa, 675-0 011; JA 675-0011
• MDR Report Key: 9450949
• Report Number: 1000515253-2019-00021
• Device Sequence Number: 11414628
• 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): 12/11/2019

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: 11/13/2019
• Initial Report FDA Received Date: 12/11/2019
• 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