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

Model Number CA-660

Device Problem Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/06/2021

Event Type  Injury  

Manufacturer Narrative

Sysmex became aware of the treatment change based on the erroneous results on 06/09/2021.The ca-600 instructions for use,chapter 5 - operation, section 5.13 - automatic inquiry, states: the sample id number (nos).For one rack are read from the barcode labels, and inquiries are made to the host computer for those id nos.When the analysis information is received, it is displayed on the screen and analysis is started.The user reported removing the sample rack prematurely.In normal operation, when a sample rack is placed on the analyzer and the start button is pressed, the barcode of each sample is read on the ca-500/600 series analyzers.If an error occurs for any reason after reading the sample barcodes, the analyzer enters a standby mode awaiting resolution by the operator before resuming analysis.The order and patient information from the first rack is retained within the system.At this point, sample aspiration for analysis has not occurred.If the operator incorrectly removes the sample rack and replaces it with a different rack in standby mode, the analyzer would not detect the exchange.After error recovery, sample aspiration for analysis would initiate.The retained order and patient information would be applied to the new sample rack.The root cause could not be confirmed with the information provided.No analyzer deficiency was identified.

Event Description

A user in (b)(6) reported incorrect prothrombin (pt) and international normalized ratio (inr) results led to a patient experiencing a warfarin dosage change.A rack containing five patient samples was placed on the analyzer.The analyzer scanned the barcode of each sample in the rack which generated a sample worklist.The rack was removed prematurely by the operator before sample aspiration began.Another rack of patient samples was placed on the analyzer.As the second rack of samples was analyzed, results were applied to patient id/demographics from the worklist from the first rack.This caused incorrect pt/inr results to be released to the physician.The operator reanalyzed the samples on a different analyzer and corrected reports were issued.One patient experienced a change in their warfarin dose based on the erroneous low pt/inr results that were originally reported.Details of the warfarin dosage change, timeframe of the treatment and patient diagnosis were not provided.There was no alleged patient harm due to the change in the warfarin treatment.There was no report of negative patient impact for the other four samples contained in the first rack.

• Brand Name: SYSMEX CA-660
• Type of Device: AUTOMATED COAGULATION ANALYZER
• Manufacturer (Section D): SYSMEX RA CO., LTD. MAIN PLANT; 1850-3 hirooka-nomura; shiojiri, nagano 399-0 702; JA 399-0702
• Manufacturer (Section G): SYSMEX RA CO., LTD. MAIN PLANT; 1850-3 hirooka-nomura; shiojiri, nagano 399-0 702; JA 399-0702
• Manufacturer Contact: karen bieletzki ; 577 aptakisic rd; lincolnshire, IL 60069 ; 2245439710
• MDR Report Key: 12124807
• MDR Text Key: 260253880
• Report Number: 1000515253-2021-00011
• 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: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CA-660
• Device Catalogue Number: CK978289
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/09/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/21/2015
• 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