MAUDE Adverse Event Report: SYSMEX CORPORATION CS-2000I; AUTOMATED BLOOD COAGULATION ANALYZER

Model Number CS-2000I

Device Problem Use of Incorrect Control/Treatment Settings (1126)

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

Event Date 04/21/2020

Event Type  Injury  

Manufacturer Narrative

Investigation determined the sysmex service engineer (se) applied erroneous integer and decimal settings for the user's d-dimer assay.The user's d-dimer assay was set originally to output result values consisting of an integer of 3 digits and a decimal of 2 digits.The se applied an incorrect output integer setting of 4 digits and an incorrect output decimal of 1 digit.D-dimer result values displayed correctly on the analyzer but transmitted to the laboratory information system (lis) as one-tenth (1/10) of the actual measured value.A service engineer corrected the integer and decimal settings on (b)(6) 2020.

Event Description

The user in (b)(6) reported lixiana (oral anticoagulant) administration was discontinued prematurely for one patient due to an erroneous low reported d-dimer result on (b)(6) 2020.The patient was discharged on (b)(6) 2020.There was no reported harm to the patient due to the premature discontinuation of lixiana.

• Brand Name: CS-2000I
• Type of Device: AUTOMATED BLOOD COAGULATION ANALYZER
• Manufacturer (Section D): SYSMEX CORPORATION; 314-2 kitano; noguchi-cho; kakogawa, hyogo 675-0 011; JA 675-0011
• Manufacturer (Section G): SYSMEX CORPORATION; 314-2 kitano; noguchi-cho; kakogawa, hyogo 675-0 011; JA 675-0011
• Manufacturer Contact: nancy gould ; 577 aptakisic rd; lincolnshire, il ; 5439678
• MDR Report Key: 10219658
• MDR Text Key: 197343913
• Report Number: 1000515253-2020-00019
• Device Sequence Number: 1
• Product Code: JPA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K151259
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CS-2000I
• Device Catalogue Number: 06372511
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/06/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/02/2010
• 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