MAUDE Adverse Event Report: SYSMEX CORPORATION, I SQUARE CS-2500; AUTOMATED BLOOD COAGULATION ANALYZER

Model Number CS-2500

Device Problem Low Test Results (2458)

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

Event Date 03/16/2022

Event Type  Injury  

Manufacturer Narrative

D-dimer quality control (qc) recovered within expected ranges.No analysis errors were generated for the initial analysis of sid (b)(6).A service engineer (se) was dispatched on march 17, 2022.The se inspected probes and mechanical positions, syringes, and the detector block.No deficiency was identified.The event was escalated to sysmex corporation, japan (s-corp) for investigation of root cause.S-corp performed a review of available data.Multiple instances of error code 10740 and error code 10748 were documented in the analyzer log files for sample analyses before and after the initial analysis of sid (b)(6).S-corp determined, this data suggests inadequate sample aspiration caused the event.Root cause of the aspiration issue could not be determined.The sysmex automated blood coagulation analyzer cs-2500 is a fully automated blood coagulation analyzer intended for in vitro diagnostic use using plasma collected from venous blood samples in 3.2 % sodium citrate tubes to analyze clotting, chromogenic and immunoassay methods in the clinical laboratory.The cs-2500 instructions for use (ifu), chapter 2 - principles of operation, section 2.1 - system overview, cautions the user: "results should always be evaluated in conjunction with clinical and other laboratory findings".Chapter 8 - troubleshooting, section 8.5.1 - causes of errors and corrective actions, describes error codes, their probable cause and corrective action.For errors 10740 and 10748, the following information is provided to the user: 10740 - insufficient sample (liquid surface not detected) ("rack no.- tube pos.").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.Corrective action set the sample with required volume and analyze again.Check the sample.If error persists, contact your service representative.10748 - abnormal sample volume (sample table primary dispensing) ("rack no.- tube pos.").Probable cause: the error in primary dispensing and aspiration occurs due to bubbles or clotting.The liquid surface sensor has failed.The failure or incorrect positioning of the sample dispensing mechanism.The failure or incorrect positioning of the sample aspiration table.Corrective action: check the sample.The device log further documents frequent "defective sample volume" messages being generated prior to analysis of sid (b)(6).Section 8.5.3 - displaying sample information, informs the user of the [joblist] screen and the [detail] dialog box, which display the result of the inhibitor check in the sample and the result of the sample volume check.The user is informed: code 1100.4000.0000 [defective sample volume].Possible cause: sample suspected of inappropriate volume.Corrective actions: check the reaction curve and follow judgment criteria for the institution.Root cause of the event is undetermined.The analyzer generated frequent error code messages related to sample aspiration and sample volume throughout the day of the event.It is possible an air bubble or (micro-) clot aspiration contributed to the event.This however could not be confirmed.

Event Description

The patient presented to the emergency room on (b)(6) 2022, with elevated temperature and leg pain.A sample for d-dimer testing was collected and submitted for analysis.The result generated was normal.The patient was discharged.The patient's sample was repeated later the same day for lab correlation studies.Repeat analysis generated elevated d-dimer results.The patient was recalled for collection of a repeat sample the following day.Analysis of this sample also generated elevated d-dimer test results.Administration of tinzaparin was started, on (b)(6) 2022 (time not provided).Ultrasound (us) compression venography was scheduled for the following day.On (b)(6) 2022 us compression venography concluded positive for calf deep vein thrombosis (dvt) and administration of apixaban was started (time not provided).Per the user, the patient experienced a delay in diagnostic testing and anticoagulant therapy due to the erroneous low d-dimer results reported.No serious injury or harm to the patient due to the delay in treatment was reported.

• Brand Name: CS-2500
• Type of Device: AUTOMATED BLOOD COAGULATION 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: nancy gould ; 577 aptakisic rd; lincolnshire, IL 60069 ; 2245439710
• MDR Report Key: 14104394
• MDR Text Key: 294577603
• Report Number: 1000515253-2022-00004
• Device Sequence Number: 1
• Product Code: JPA
• UDI-Device Identifier: 04987562433735
• UDI-Public: (01)04987562433735(11)170407
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K172286
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CS-2500
• Device Catalogue Number: BV981798
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/10/2017
• 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: 72 YR
• Patient Sex: Male