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U.S. Department of Health and Human Services

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

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SYSMEX CORPORATION, I SQUARE XN-10; AUTOMATED HEMATOLOGY ANALYZER Back to Search Results
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.
 
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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 Key7555161
MDR Text Key109613395
Report Number1000515253-2018-00007
Device Sequence Number1
Product Code GKZ
UDI-Device Identifier04987562424214
UDI-Public(01)04987562424214
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K112605
Number of Events Reported1
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 NumberXN-10
Device Catalogue NumberAP795756
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 Received05/30/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/11/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age2 DA
Patient Weight2
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