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	01/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The sysmex cs-2500 evaluation and check algorithm document states "early reaction error" messages occur when an early reaction causes abnormally short aptt results.When this situation occurs, no numerical results will be generated.Instead, asterisks will display along with the error message.The user is to verify sample and reagent integrity, and repeat analysis.Once the error clears, the result can be reported.The user failed to repeat analysis and clear the error prior to result reporting.The samples generated "early reaction error" errors and a "wave changed 800nm" error.Chapter 8 - troubleshooting, section 8.5.2 - analysis data errors, displays the various producible errors and the meanings associated with the errors."early reaction error" errors are generated when an abnormal reaction is detected at the initial stage of the aptt coagulation reaction.The user is to check the coagulation curve and follow the judgment criteria established by the laboratory."wave changed 800nm" errors are generated when the wavelength changed to reduce the impact of interference.The user is to review the coagulation curve for abnormalities and repeat analysis, if indicated.It is unknown if the user was following laboratory standard operating procedure (sop) by reporting the 50% coagulation time value.Reporting the 50% coagulation time value is not recommended by the manufacturer for these error messages.Sysmex corporation (b)(4) (s-corp) performed the investigation.The investigation determined the analyzer performed as designed by alerting the user to sample abnormality.
Event or Problem Description
A sample was analyzed for an activated partial thromboplastin time (aptt).The analyzer generated "early reaction error: slow reaction" and "early reaction error: early %" errors.The result was displayed as asterisks [*].The user reported an aptt result based on the 50% coagulation time value generated by the analyzer.The physician administered heparin due to the result.The dosage is unknown.An additional sample was collected and sent to a reference lab for testing.The reference laboratory generated an aptt result of >400 seconds (sec).Three subsequent samples from the same patient were analyzed for an aptt on the same day.All samples generated "early reaction error: early %", "early reaction error: slow reaction", and/or "wave changed 800nm" errors.All aptt results were displayed as asterisks.The user reported aptt results for all samples based on the 50% coagulation time value generated by the analyzer.Erroneous aptt results were reported.The correct aptt values are unknown.It is unknown if corrected reports were issued.The patient received unnecessary heparin administration due to the result reported for the first sample.No harm was reported due to heparin administration.

• 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: 8461647
• Report Number: 1000515253-2019-00008
• Device Sequence Number: 2926416
• Product Code: JPA
• UDI-Device Identifier: 04987562433735
• UDI-Public: (01)04987562433735(11)170307
• 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,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/28/2019

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: 02/27/2019
• Initial Report FDA Received Date: 03/28/2019
• 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