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

Model Number	CS-2500
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The sysmex cs-2500 is a screening device used for monitoring anti-coagulant therapy and identification of coagulation abnormalities.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." per the ifu, chapter 2, principles of operation, "the following is displayed if there is an error in the analysis result: meaning analysis result could not be obtained due to errors and other problems".The cs-2500 ifu, chapter 8 - troubleshooting, section 8.5 - error message list, provides a listing of error messages for this instrument and their causes/corrective actions are as follows.The following information is provided for the error generated by the sample analyses: message: early reaction error: early %.Possible cause: an abnormal reaction was detected at the initial stage of the aptt coagulation reaction.Corrective actions/ countermeasures: check the coagulation curve and follow the judgment criteria for your institution.Alternatively, check the volumes of sample and reagent, then repeat the test.The analyzer performed as designed by alerting the operator to possible sample abnormality requiring further verification of accurate results prior to reporting.A sample/patient specific abnormality could not be ruled out as a contributing factor.No systemic product deficiency was identified.
Event or Problem Description
The sample was analyzed for an activated partial thromboplastin time (aptt).No numerical value was generated with an "early reaction error (early %)".The user reviewed the coagulation curve and reported a numerical value for the aptt.The patient's therapy was changed from heparin to argatroban based on the numerical result.No patient harm was reported based on the administration of argatroban.

• Brand Name: CS-2500
• Common Device Name: 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
• MDR Report Key: 9935571
• Report Number: 1000515253-2020-00014
• Device Sequence Number: 2497643
• Product Code: JPA
• UDI-Device Identifier: 04987562433735
• UDI-Public: (01)04987562433735(11)170615
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K172286
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/07/2020

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
• Operator of Device: Health Professional
• Device Model Number: CS-2500
• Device Catalogue Number: BV981798
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2020
• Initial Report FDA Received Date: 04/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other