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

Model Number	CS-2500
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The sysmex cs-2500 instructions for use (ifu), chapter 8 - troubleshooting, section 8.5.2 - analysis data errors, states for error code 0008.0128.002: [early reaction error: start angle 1], "an abnormal reaction was detected at the initial stage of the aptt coagulation reaction.Check the coagulation curve and follow the judgment criteria for your institution.Alternatively, check the volumes of sample and reagent, then repeat the test." all analyses generated results with asterisks [*].Chapter 2 - principles of operation, section 2.9.2 - checking the analysis result list, provides overview and interpretation of the analysis results.A numerical result with [*] indicates a low-reliability analysis result and a result of [****.*] indicates the analysis result could not be obtained due to errors and other problems.It is the responsibility of the operator to verify results prior to reporting.The laboratory manager reported the operator erroneously interpreted the flagged analyses results and failed to follow laboratory policy.Laboratory policy is to recollect the sample and send out for testing using an alternate methodology.No analyzer deficiency was identified.
Event or Problem Description
Multiple samples from the same patient were analyzed for activated partial thromboplastin time (aptt) and generated results with asterisks.The operator reviewed the coagulation curve and reported a numerical value for the aptt result.The operator reported a falsely decreased aptt result on an analysis that generated error code 0008.0128.002: [early reaction error: start angle 1].The patient was receiving intravenous heparin treatment and the treatment continued based on the erroneous aptt result.There was no harm to the patient reported due to the prolonged heparin treatment.

• 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: 11631167
• Report Number: 1000515253-2021-00008
• Device Sequence Number: 11583057
• Product Code: JPA
• UDI-Device Identifier: 04987562433735
• UDI-Public: (01)04987562433735(11)161110
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K172286
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/07/2021

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: 03/30/2021
• Initial Report FDA Received Date: 04/07/2021
• 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
• Patient Age: 63 YR