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

Model Number CA-620

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/05/2019

Event Type  Injury  

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 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
• Type of Device: AUTOMATED BLOOD COAGULATION ANALYZER
• Manufacturer (Section D): SYSMEX RA CO. LTD.; 1850-3 hirookanomura; shiojiri, 399-0 702; JA 399-0702
• Manufacturer (Section G): SYSMEX RA CO. LTD.; 1850-3 hirookanomura; shiojiri, 399-0 702; JA 399-0702
• Manufacturer Contact: nancy gould ; 577 aptakisic rd; lincolnshire, IL 60069 ; 2245439678
• MDR Report Key: 9440312
• MDR Text Key: 174658822
• Report Number: 1000515253-2019-00020
• Device Sequence Number: 1
• Product Code: GKP
• UDI-Device Identifier: 04987562425686
• UDI-Public: 0104987562425686
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K031377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CA-620
• Device Catalogue Number: BR142626
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/28/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/31/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 85 YR