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

Model Number	XN-10
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/29/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The sysmex xn-2000 instruction 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 messages are classified into positive/negative based on the preset criteria.The system bases its judgments on comprehensive surveys of numerical data, particle size distributions, scattergrams, and provides easily-to-understand flags/messages indicating the instruments findings.These flags/messages are referred to as "ip (interpretive program) messages." the operator is cautioned: 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 sysmex xn-2000 ifu, chapter 15 - technical information, normal reference interval states the normal reference range for plt for females is 182-369 x 10^3/ul.The user erroneously released the results prior to additional verification.
Event or Problem Description
The sample was analyzed generating a decreased impedance platelet (plt-i) count of 43 x 10^3/ul.The sample was reanalyzed the same day for a fluorescence plt ( plt-f) and generated a plt-f zero value.The user reported a plt result of less than 4 x 10^3/ul to the laboratory information system (lis).A peripheral smear was prepared and the plt estimate was reported as "decreased".The patient was transfused one unit of platelets based on the reported results.A new blood sample was collected and analyzed post transfusion, generating a plt count of 72 x 10^3/ul.Repeat analysis for plt-f generated a zero value.A slide was prepared and the plt estimate did not agree with the plt-f result.The sample was repeated two more times for plt analysis, generating plt results of 69 x 10^3/ul and 71 x 10^3/ul.The user reported a plt result of 69 x 10^3/ul and a plt estimate of "decreased" to the lis.A corrected report was issued for the initial sample to change the plt result from a value of < 4 x 10^3/ul to a plt value of 43 x 10^3/ul.There was no known negative impact from the transfusion for the involved patient.

• Brand Name: 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: 8283610
• Report Number: 1000515253-2019-00004
• Device Sequence Number: 1259363
• Product Code: GKZ
• UDI-Device Identifier: 04987562424214
• UDI-Public: (01)04987562424214
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 01/28/2019

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: 12/30/2018
• Initial Report FDA Received Date: 01/28/2019
• 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