MAUDE Adverse Event Report: COAGUSENSE, INC; TEST, TIME, PROTHROMBIN

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Test Result (2695)

Event Date 12/10/2019

Event Type  malfunction  

Event Description

The patient had an international normalized ratio (inr) done in the office.His inr was 2.1.His coumadin is managed by the coumadin clinic and when he reported it to them, he was told that it did not seem right.So, he was told to go to a lab to have it repeated.He went to the lab and had the inr repeated and it was 3.2.Call received from coumadin clinic the following day to report the discrepancy of the patients inr readings.

• Type of Device: TEST, TIME, PROTHROMBIN
• Manufacturer (Section D): COAGUSENSE, INC; 48377 fremont blvd ste 113; fremont CA 94538
• MDR Report Key: 9864932
• MDR Text Key: 184481448
• Report Number: 9864932
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/11/2020
• Event Location: Other
• Date Report to Manufacturer: 03/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1