MAUDE Adverse Event Report: SYSMEX RA CO., LTD. MAIN PLANT SYSMEX SP-50; AUTOMATED SLIDE PREPARATION UNIT

Model Number SP-50

Device Problem Communication or Transmission Problem (2896)

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

Event Date 12/04/2018

Event Type  malfunction  

Manufacturer Narrative

A service engineer (se) was dispatched and unable to find any technical issues with the slide preparer.All other patient samples printed correctly.Sysmex corporation (b)(4) (s-corp) performed the investigation and determined a software program defect contributed to the event.The internal processing unit (ipu) transmits patient information to the device control manager (dcm) program.The dcm program then sends the patient information to the printer.The ipu program is allowed 25 seconds to transmit patient information to the dcm program.S-corp found the transmission of the patient information from the ipu program to the dcm program was delayed greater than 25 seconds.The dcm program did not wait for the patient information to be transmitted and erroneously instructed the printer to print the previous patient information on the slide.S-corp is developing a countermeasure to resolve the issue.The countermeasure will include reducing the delay of transmission of patient information from the ipu program to the dcm program and requiring the dcm to delete all patient information after printing.When blood smears are misidentified, there is a risk for incorrect differential result reporting.Physicians who are familiar with the patient's history and other clinical signs and symptoms request verification of results with repeat sample collection and testing for inconsistent, unexplainable results prior to making clinical decisions.Good laboratory practice and regulatory requirements, mandates a system be in place for confirming and reporting abnormal values and/or significant changes in patient test results, employing user-defined delta checks, data and printout reviews, and correlation with peripheral smears.The user appropriately verified patient information prior to result reporting.

Event Description

A user in (b)(6) reported the slide preparer incorrectly labeled patient slides.A sample was analyzed, and a slide was created.The slide preparer accurately labeled the slide.A second sample was analyzed, and a slide was created.The slide preparer incorrectly labeled the slide with the patient information from the previous sample.No analyzer errors were generated.The issue of incorrect slide labeling was obvious to the user.No erroneous results were reported and no corrected reports were issued.No negative impact to patient management was reported.

Manufacturer Narrative

S-corp determined the delay in transmission of the patient information from the ipu program to the dcm program was due to the ipu program being under heavy load decreasing program memory.The user had installed an unapproved remote service application that contributed to the heavy load and decrease in ipu memory.Review of the complaint database reveals there has been no other complaints of this type.S-corp has developed the following countermeasures in the next version of software (v2.17) to prevent future recurrence.The dcm will print the sample information as soon as the information has been transmitted from the ipu.The dcm cache will then be cleared after each sample information is printed.This way the dcm program will not retain previous sample information to inadvertently assign to another sample.An upgrade to the.Net framework version will reduce memory usage.The development of the software upgrade is due to complete april 15, 2019.The sp-50 is marketed and sold in the u.S.As part of an xn series automated line or as a standalone.

• Brand Name: SYSMEX SP-50
• Type of Device: AUTOMATED SLIDE PREPARATION UNIT
• Manufacturer (Section D): SYSMEX RA CO., LTD. MAIN PLANT; 1850-3 hirooka-nomura; shiojiri, nagano 399-0 702; JA 399-0702
• MDR Report Key: 8255041
• MDR Text Key: 133537316
• Report Number: 1000515253-2019-00002
• Device Sequence Number: 1
• Product Code: KPA
• UDI-Device Identifier: 04987562468041
• UDI-Public: 0104987562468041
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 04/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: SP-50
• Device Catalogue Number: BX765805
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1