MAUDE Adverse Event Report: SYSMEX CORP SYSMEX XN-10 ANALYZER; AUTOMATED HEMOTOLOGY ANALYZER

Model Number XN-10

Device Problem Low Test Results (2458)

Patient Problem Misdiagnosis (2159)

Event Date 08/18/2014

Event Type  Other  

Event Description

False low platelet (plt) values and lack of a plt clump flag were obtained when samples form a single patient were run on both analyzers during a four-day period beginning (b)(6) 2014.The samples came from a (b)(6) male who was scheduled for surgery (the specific procedure is unk).Sample id (b)(6), was run for a cbc only on analyzer xn-9000-2-a at 12:39 on (b)(6).The plt count was 23 x 10^3/ul.The sample was judged "positive" with a count error.The interpretive program (ip) message thrombocytopenia was generated.If an error/ rule comment was generated, it was not provided.It is unk if the sample was repeated.A second sample, sample id (b)(6), was collected approx four hours later at 16:18 on (b)(6).That sample generated a platelet count of 13 x 10^3/ul.This data could not be found in the sample explorer listing on the xn-10.The user stated that this sample possibly was run on another manufacturer's analyzer, an lh-750 (beckman coulter).Based upon these low counts, the patient received four units of single-donor platelets.The specific date and time of platelet administration is unk.

Manufacturer Narrative

This issue is being reported because the patient was given for units of single-donor platelets, which likely were unnecessary, carrying with them the possibility of bacterial or viral infection, exposure to blood-borne pathogens and transfusion reactions.An accurate platelet count was not provided and investigation into this sample-specific issue was not sufficient to eliminate the possibility of recurrence.This event was produced by use error.The samples in question all were judged positive with count errors and the thrombocytopenia interpretive program (ip) message.These alert the operator to sample abnormality and need for verification of the platelet count before erroneous counts were reported.The plt histogram was abnormal; not smooth and without a distinguishable peak.The analyzer's instructions for us (ifu) was not followed.The user is advised to repeat the sample through the plt-f channel in the cases of low platelet counts.Analysis through more channels (wnr, wdf) allows for additional data collection that is used to distinguish between cell types and generates the plt clump flag.The ifu warns of the possibility that erroneous low counts may be generated when one of the following exist: plt clumps, giant platelets, and pseudothrombocytopenia (platelet clumps when sample is exposed to edta anti-coagulant due to the presence of abnormal antibodies).The user also did not review the feathered edge of a peripheral smear until (b)(6) when platelet clumps were discovered.

• Brand Name: SYSMEX XN-10 ANALYZER
• Type of Device: AUTOMATED HEMOTOLOGY ANALYZER
• Manufacturer (Section D): SYSMEX CORP; kakogawa ; JA
• Manufacturer (Section G): SYSMEX CORP; 314-2 kitano, noguchicho; kakogawa 675- 0011; JA 675-0011
• Manufacturer Contact: peter shearstone, vp ; 577 aptakisic rd; lincolnshire, IL 60069 ; 2245439514
• MDR Report Key: 4147248
• MDR Text Key: 4765074
• Report Number: 3009711478-2014-00021
• Device Sequence Number: 1
• Product Code: GKZ
• 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,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: XN-10
• Device Catalogue Number: AP795756
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2013
• 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 Age: 66 YR