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

Model Number	CS-2500
Medical Device Problem Codes	Misconnection (1399); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/09/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The user reported that the initial result had a "low defective sampling" error, which alerted the operator to verify the sample result.The sysmex cs-2500 instructions for use ( ifu) does not contain documentation of this specific error message.Siemens contacted the user for confirmation and objective evidence of the specific error code, however the user did not provide any additional information.The sysmex cs-2500 ifu, chapter 2, principles of operation, section 2.8.9.5 - replenishing rinse water, instructs the user: "use purified water for the rinse water." the user installed the incorrect reagent for sample processing.Within the sysmex cs-2500 ifu, chapter 1 - introduction, it is stated: " data generated by cs-2500 is not intended to replace professional judgment in the determination of a diagnosis or in monitoring patient therapy.Operate the instrument as instructed.Reliability of test results cannot be guaranteed if there are any deviations from the instructions in this manual.If the instrument fails to function properly as a result of either the user's operation not specified in this manual or the user's utilization of a program not specified by sysmex, the product warranty would not apply".
Event or Problem Description
The user reported saline was erroneously connected to the analyzer instead of rinse water.The user reported that quality control (qc) results were in range when saline was in use and that patient results were reported for prothrombin time (pt) / international normalized ratio (inr).The laboratory installed and primed the rinse water the following day and repeated the affected samples.One discordant pt/inr result for a patient on anticoagulant therapy was found.The initial sample had been reported with falsely elevated pt/inr results.Upon further review of the original result, the laboratory found there had been an indication of a "low defective sampling error".The patient's anticoagulant dosage had been changed based on the incorrect result.Anticoagulant therapy dosage prior to the event and in response to the event was not provided.The repeat analysis of the sample produced pt/inr results that were consistent with the patient's prior history.The patient returned for pt/inr testing four days after the initial collection.Test results obtained on this sample were decreased, compared to the repeat testing of the initial sample.There was no report of patient harm due to the change in anticoagulant therapy.

• Brand Name: SYSMEX 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: 8236999
• Report Number: 1000515253-2019-00001
• Device Sequence Number: 19310398
• Product Code: JPA
• UDI-Device Identifier: 04987562433735
• UDI-Public: (01)04987562433735(11)161116
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K172286
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/10/2019

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: 12/11/2018
• Initial Report FDA Received Date: 01/10/2019
• 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