MAUDE Adverse Event Report: SYSMEX RA CO. LTD. CA-620; AUTOMATED BLOOD COAGULATION ANALYZER

Model Number	CA-620
Medical Device Problem Codes	Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The sysmex ca-600 series instructions for use (ifu), chapter 12 - troubleshooting, section 12.1 - introduction, informs the user: "when an error occurs in a sample, the analysis data relative to the error is displayed "***.Repeat analysis is required in the case of either an instrument error or an analysis error (shown as "***.In the stored data and on print out)." additionally, analysis data error, informs the user of error codes and messages that may accompany a result and provides probable cause for the error as well as actions / steps to undertake to resolve the issue.For the "clotting method", the "no coagulation flag" err[32], the ifu indicates: "coagulation reaction can not be detected".The ifu further states as an action/step: "make comprehensive judgment, taking various aspects into consideration, including whether or not any error is involved in samples (storage status, blood collecting procedure, etc.) and reagents (storage status)." the analyzer performed as designed by alerting the operator that results needed verification prior to reporting.The operator failed to follow the troubleshooting steps for the "no coagulation" flag and did not verify the results prior to release.
Event or Problem Description
A sample was analyzed and generated asterisks with a "no coagulation" flag instead of a numeric protime (pt) result.The user reported the pt result as "no coagulation" to the physician.The patient was administered 5mg vitamin k (mephyton).No harm to the patient due to the administration of vitamin k was reported.

• Brand Name: CA-620
• Common Device Name: AUTOMATED BLOOD COAGULATION ANALYZER
• Manufacturer (Section D): SYSMEX RA CO. LTD.; 1850-3 hirookanomura; shiojiri, 399-0 702; JA 399-0702
• MDR Report Key: 9440312
• Report Number: 1000515253-2019-00020
• Device Sequence Number: 3999317
• Product Code: GKP
• UDI-Device Identifier: 04987562425686
• UDI-Public: 0104987562425686
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K031377
• Number of Events Summarized: 1
• Summary Report (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): 12/09/2019

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: CA-620
• Device Catalogue Number: BR142626
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2019
• Initial Report FDA Received Date: 12/09/2019
• 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
• Patient Age: 85 YR