MAUDE Adverse Event Report: SYSMEX CORPORATION XN-550; AUTOMATED HEMATOLOGY ANALYZER

Model Number	XN-550
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The xn-550 online manual - troubleshooting chapter 1, describes the various situations related to the blood aspiration.A probable cause for the insufficient blood volume (short sample) error is if the blood is very thin.This indicates the aspiration sensor cannot detect the blood.The user is directed on the screen to "touch [accept] in the [help] dialog box" and the corrective action is displayed on the screen.The user can stop use of the aspiration sensor temporarily in the settings and perform repeat analysis.For details on enabling/disabling the aspiration sensor settings, see "basic operation".(basic operation, "chapter 7: 7.9.1 aspiration sensor settings").It was determined the instrument performed as designed.It was discussed that critical low hgb could cause this insufficient blood volume error and that this is noted in the troubleshooting guide.It was explained to the user how to disable this sensor in both the analyzer settings and in the manual analysis settings when running a specimen in manual mode.
Event or Problem Description
The patient's sample was analyzed and the analyzer generated "insufficient blood volume (short sample)" errors.Results were displayed as dashes (---), indicating enumeration was not possible.The sample was repeated two more times with the same results.The user performed the rbc detector clog three times and no clot was observed.The user then checked the sample for clots, however none were detected.The patient was recollected to further rule out a clotted specimen.The recollected sample analysis generated the same error.The user performed a cleaning procedure and repeated the sample, however the error persisted.The user then sent the sample tube to a reference lab.The reference lab results indicated a hemoglobin (hgb) of 3.2 g/dl.A crossmatch for one packed rbc was ordered and transfused.The user attempted to troubleshoot by disabling the aspiration sensor in the analyzer settings and then repeated the original sample.The analyzer generated a hgb of 3.2 g/dl, which matched the result from the reference lab.The user alleged the rbc transfusion was delayed 2 hours due to the analyzer not generating numerical values.No harm to the patient was reported based on this delay.

• Brand Name: XN-550
• Common Device Name: AUTOMATED HEMATOLOGY ANALYZER
• Manufacturer (Section D): SYSMEX CORPORATION; 314-2 kitano; noguchi-cho; kakogawa, hyogo 675-0 011; JA 675-0011
• MDR Report Key: 8341678
• Report Number: 1000515253-2019-00006
• Device Sequence Number: 14024444
• Product Code: GKZ
• UDI-Device Identifier: 04987562434572
• UDI-Public: 4987562434572
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K182389
• Number of Events Summarized: 1
• Summary Report (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): 02/14/2019

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-550
• Device Catalogue Number: BD634545
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2019
• Initial Report FDA Received Date: 02/14/2019
• 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: 67 YR
• Patient Weight: 83