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

Model Number	CS-2500
Medical Device Problem Codes	Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Sysmex became aware of the treatment change based on the erroneous results on (b)(6)2021.The operator was using cs-2500 software version 01-68 at the time of this event.The operator stated use of becton dickinson and company (bd) 1.8 ml and 2.7 ml sodium citrate sample tubes.The cs-2500 instructions for use (ifu) version 01-68, chapter 1 introduction, section 1.5.4 usable sample tubes - demonstrates software settings available in software version 01-68 are incompatible with combined use of both bd 1.8ml and 2.7ml sample tubes.Sample tube type settings can be engaged for either bd 1.8ml or bd 2.7ml sample tubes.It is unknown what tube type setting or what sample tube type was utilized for the suspect analysis.The initial analysis generated error code 0000.4000.0041 [extrapolation boundary over (upper)].Chapter 8 troubleshooting, section 8.5.2 analysis data errors - states that the possible cause is the "analysis results exceeded the calibration curve extrapolation range and the corrective actions/countermeasures states to refer to the reagent application sheet.If allowable, change the dilution ratio, then repeat the analysis.Not all assays permit alternate sample dilution ratios." innovance heparin does not permit alternate sample dilution ratios.The operator reported the result as the upper reportable range limit of 1.5 iu/ml.The laboratory policy is to investigate invalid results or results marked for review.If no sample integrity concerns are found and analyzer performance is not in question, results may be reported according to the heparin analytical measuring range, which is 0.10 ml-1.5 ml.The operator changed the reagent then analyzed and reported patient results prior to analyzing quality control (qc).It is good laboratory practice to analyze qc post reagent change prior to patient analysis to ensure accuracy of results.Qc analysis post reagent change generated error code 4004.000.000 [no linearity].Chapter 8 troubleshooting, section 8.5.2 analysis data errors - states that the possible cause is the "reaction curve lacked linearity and the corrective actions/countermeasures states to check the reaction curve." further verification of analyzer performance was recommended.No analyzer deficiency was identified.
Event or Problem Description
An erroneous heparin result was reported to the medical team.Prior to the initial sample analysis, quality control (qc) was analyzed generating results within range.The operator changed the innovance heparin reagent and analyzed the patient sample.The initial analysis generated an error code and the result was reported to the medical team as the upper reportable range limit.Next, qc was analyzed and generated an error code.Reanalysis generated qc results that were out of range.The reagent was changed and qc was analyzed generating results out of range.A new vial of qc was analyzed generating results within range.The patient sample was reanalyzed generating an accurate heparin result.Additionally, the result was verified on a second analyzer.A corrected report was issued.The patient's heparin treatment was stopped due to the erroneous result.There was no report of injury to the patient.

• 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: 12229687
• Report Number: 1000515253-2021-00012
• Device Sequence Number: 3802653
• Product Code: JPA
• UDI-Device Identifier: 04987562433735
• UDI-Public: (01)04987562433735(11)170613
• 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): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/26/2021

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: 07/05/2021
• Initial Report FDA Received Date: 07/27/2021
• 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; Required Intervention