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

Model Number	XN-10
Medical Device Problem Codes	Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/29/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The analyzer alerted the operator to sample abnormality requiring further verification prior to result reporting.It is common for newborns to have nrbcs present in the blood, which are known to falsely elevate wbc values.The operator failed to verify accurate results prior to reporting.
Event or Problem Description
A newborn was administered gentamycin due to an erroneously high white blood cell (wbc) result.The sample was analyzed for a complete blood count and differential.The sample was judged "positive" indicating the need for further review of the sample prior to result reporting.Repeat analysis was performed, and the sample was judged "positive" with an increased wbc value.A smear review was performed and the presence of many nucleated red blood cells (nrbcs) was observed.The user failed to correct the wbc value for the presence of nrbcs prior to releasing the wbc value.An order was written to administer 2 mg/ml of gentamycin on (b)(6) 2018 at 06:45.It is unknown when the antibiotic was administered.It is unknown if other clinical signs and symptoms warranted the antibiotic treatment.No negative impact to the patient was reported.

• 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: 7555161
• Report Number: 1000515253-2018-00007
• Device Sequence Number: 2194319
• Product Code: GKZ
• UDI-Device Identifier: 04987562424214
• UDI-Public: (01)04987562424214
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: Medical Technologist
• Type of Report: Initial
• Report Date (Section B): 05/30/2018

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: XN-10
• Device Catalogue Number: AP795756
• 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: 04/30/2018
• Initial Report FDA Received Date: 05/30/2018
• 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: 2 DA
• Patient Weight: 2