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

Model Number XN-10

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/29/2018

Event Type  Injury  

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 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
• Type of Device: AUTOMATED HEMATOLOGY ANALYZER
• Manufacturer (Section D): SYSMEX CORPORATION, I SQUARE; 262-11 mizuashi; noguchi-cho; kakogawa-city, hyogo 675-0 019; JA 675-0019
• Manufacturer (Section G): SYSMEX CORPORATION, I SQUARE; 262-11 mizuashi; noguchi-cho; kakogawa-city, hyogo 675-0 019; JA 675-0019
• Manufacturer Contact: peter shearstone ; 577 aptakisic rd; lincolnshire, IL 60069 ; 2245439514
• MDR Report Key: 7555161
• MDR Text Key: 109613395
• Report Number: 1000515253-2018-00007
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 04987562424214
• UDI-Public: (01)04987562424214
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112605
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Medical Technologist
• Type of Report: Initial
• Report Date: 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
• Device Operator: Medical Technologist
• Device Model Number: XN-10
• Device Catalogue Number: AP795756
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/30/2018
• Initial Date FDA Received: 05/30/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/11/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 2 DA
• Patient Weight: 2