MAUDE Adverse Event Report: ROCHE COAGUCHEK HOME METER; TEST, TIME, PROTHROMBIN

Device Problem High Test Results (2457)

Patient Problem No Information (3190)

Event Date 10/18/2018

Event Type  malfunction  

Event Description

Home inr monitor check: roche home monitor inr in clinic was 3.3.Lab inr was 2.5.The roche monitor would have led us to hold coumadin.The lab inr was in range and no dose change was made.

• Brand Name: COAGUCHEK HOME METER
• Type of Device: TEST, TIME, PROTHROMBIN
• Manufacturer (Section D): ROCHE; 9115 hague road; indianapolis IN 46250
• MDR Report Key: 8023349
• MDR Text Key: 125608951
• Report Number: 8023349
• 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: 10/25/2018

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: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/25/2018
• Event Location: Home
• Date Report to Manufacturer: 10/31/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 24455 DA