MAUDE Adverse Event Report: SYSMEX CORPORATION SYSMEX CS-2100I; AUTOMATED COAGULATION ANALYZER

Model Number CS-2100I

Device Problem High Readings (2459)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/21/2021

Event Type  Injury  

Manufacturer Narrative

The user stated initial analysis of sample id (b)(6) was accompanied by insufficient sample error codes.Review of the analyzer error log reveals insufficient sample (liquid surface not detected) errors being generated on 5.15.2021 at 10:33:56, 22:04:55, 22:38:21 and on 5.16.2021 at 00:32:31, 00:55:07, and 03:41:58.The generation of errors would alert the user to an issue that needs to be resolved prior to resuming sample analysis.The cs-2000i / cs-2100i instructions for use (ifu), chapter 8 - troubleshooting, describes the insufficient sample (liquid surface not detected) error as follows: probable cause: the sample volume is insufficient.The sample is not set.The liquid surface sensor has failed.The error in sample aspiration occurs due to bubbles or clotting.Solution: set the sample with required volume and analyze again.Check the sample.The user requested service to inspect the analyzer.The service engineer noted bubbles in the sample probe tubing and found that the sample probe tubing was wet.Replacing the sample probe tubing resolved the issue.The suspect tubing was not available for further investigation.Root cause of the event could not be determined.

Event Description

A user in (b)(6) reported the patient was unnecessarily administered vitamin k due to erroneous high prothrombin time (pt) and international normalized ratio (inr) results.The sample was analyzed, generating an insufficient sample error and no numeric pt/inr results.The sample was reanalyzed on the same analyzer and generated numeric pt/inr results that were reported.The laboratory noted several patient samples were generating higher than expected pt/inr results.The sample was reanalyzed on another analyzer, which generated lower pt/inr results.A corrected report was issued.Five days later, the patient received vitamin k treatment.No patient harm due to the unnecessary treatment was reported.

• Brand Name: SYSMEX CS-2100I
• Type of Device: AUTOMATED COAGULATION ANALYZER
• Manufacturer (Section D): SYSMEX CORPORATION; 314-2 kitano; noguchi-cho; kakogawa, hyogo 675-0 011; JA 675-0011
• Manufacturer (Section G): SYSMEX CORPORATION; 314-2 kitano; noguchi-cho; kakogawa, hyogo 675-0 011; JA 675-0011
• Manufacturer Contact: karen bieletzki ; 577 aptakisic rd; lincolnshire, IL 60069 ; 2245439710
• MDR Report Key: 12002069
• MDR Text Key: 256454393
• Report Number: 1000515253-2021-00010
• Device Sequence Number: 1
• Product Code: JPA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K162688
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CS-2100I
• Device Catalogue Number: 06372511
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/04/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2014
• 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