MAUDE Adverse Event Report: SYSMEX CORPORATION XS-1000I; AUTOMATED HEMATOLOGY ANALYZER

Model Number	XS-1000I
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/09/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A sysmex service engineer (se) was dispatched on 04/16/2018.The se inspected the filters for the rbc/hgb drain as well as the wbc reaction unit drain and found them to be partially clogged.The filters for both were replaced and routine cleaning was performed.Quality control and a precision study was performed to verify analyzer performance.Sample analyses were judged "negative" with no interpretive program (ip) message flags.Sysmex xs-1000i software guide, chapter 6, ip messages, discusses how the system bases its judgment on comprehensive surveys of numerical data, particle-size distributions, and scattergrams; providing indications of the instrument's findings through ip messages.The purpose of ip message flagging is to alert the operator to a possible sample abnormality and the need to verify results prior to reporting to a clinician.The hgb value was low for the first sample and repeat analysis at 7.7 g/dl.The user's setting for "anemia" was set at <7.0 g/dl and was insufficient to trigger the ip message flag.The default setting for ip message "anemia" is hgb < 10.0 g/dl.The aspiration sensor was deactivated by the user at the time of initial analysis.Sysmex xs-1000i instructions for use (ifu) chapter 6, operation, discusses that the instrument is equipped with a blood aspiration sensor.The aspiration sensor can be set as disabled from the main unit setting screen as an emergency measure to allow analysis of extremely low concentration blood.The results were not extremely low, however, aspiration of the sample will not be monitored when the aspiration sensor is deactivated.There is a potential that correct results may not be obtained if the sample volume is low and the sensor could not detect a "short sample" or "sample not asp error".The aspiration sensor was reactivated on (b)(6) 2018.
Event or Problem Description
On (b)(6) 2018, the analyzer generated a falsely decreased hemoglobin (hgb) result.On (b)(6) 2018, the clinician performed a colonoscopy procedure on the patient based on the low hgb result.On (b)(6) 2018, a sample was recollected and analyzed, which generated a hgb value that was within normal range.On (b)(6) 2018, repeat analysis of the original sample resulted in a hgb value that was within normal range.No negative patient impact was reported due to the colonoscopy procedure.The patient's current condition is reported as healthy.

• Brand Name: XS-1000I
• Common Device Name: AUTOMATED HEMATOLOGY ANALYZER
• Manufacturer (Section D): SYSMEX CORPORATION; 314-2 kitano; noguchi-cho; kakogawa-city, hyogo 675-0 011; JA 675-0011
• MDR Report Key: 7504669
• Report Number: 1000515253-2018-00006
• Device Sequence Number: 16201315
• Product Code: GKZ
• UDI-Device Identifier: 04987562406807
• UDI-Public: (01)04987562406807
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K060656
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Medical Technologist
• Type of Report: Initial
• Report Date (Section B): 05/10/2018

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: Medical Technologist
• Device Model Number: XS-1000I
• Device Catalogue Number: 05342311
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2018
• Initial Report FDA Received Date: 05/10/2018
• 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: 76 YR