MAUDE Adverse Event Report: SYSMEX RA CO., LTD. SYSMEX CA-660; AUTOMATED BLOOD COAGULATION ANALYZER

Model Number CA-660

Device Problem Computer Software Problem (1112)

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

Event Date 01/13/2017

Event Type  malfunction  

Manufacturer Narrative

The investigation found that after the "barcode scanner driver error", the software incorrectly unlocked the error and assigned the same sample id to the subsequent sample tubes.This was determined to be a software malfunction which will be addressed in a future software update.The error would be obvious to the user due to multiple analyses containing the same sample id.

Event Description

A sample rack containing eight sample tubes was placed on the analyzer to test for prothrombin time (pt) and an international normalized ratio (inr) tests.When reading the sample identification (id) by the built-in barcode reader, a barcode driver error occurred after reading the first sample's barcode.The system assigned the first sample id to the subsequent samples in the sample rack, giving all eight samples the same sample id.The software did not display an alert to the operator of the repeated sample ids.The operator noticed that multiple samples had the same id and did not report any of the results.There was no impact to any patient management.

• Brand Name: SYSMEX CA-660
• Type of Device: AUTOMATED BLOOD COAGULATION ANALYZER
• Manufacturer (Section D): SYSMEX RA CO., LTD.; 1850-3 hirookanomura; shiojiri; nagano, japan 399-0 702; JA 399-0702
• Manufacturer (Section G): SYSMEX RA CO., LTD.; 1850-3 hirookanomura; shiojiri; nagano, japan 399-0 702; JA 399-0702
• Manufacturer Contact: peter shearstone ; 577 aptakisic rd; lincolnshire, IL 60069
• MDR Report Key: 6452473
• MDR Text Key: 71496335
• Report Number: 1000515253-2017-00009
• Device Sequence Number: 1
• Product Code: GKP
• 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: foreign
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 04/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Technologist
• Device Model Number: CA-660
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/19/2017
• Initial Date FDA Received: 04/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/27/2014
• 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