MAUDE Adverse Event Report: ROCHE DIABETES CARE, INC. COAGUCHECK HOME METER; TEST, TIME, PROTHROMBIN

Device Problem Inaccurate Information (4051)

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

Event Date 10/08/2018

Event Type  malfunction  

Event Description

Home inr monitor comparison: patient's home inr monitor read 2.1 and the lab result was 1.7.This difference is concerning because it means the difference in not changing the treatment plan (inr of 2.1) and treating the patient with lovenox and adjusting coumadin to lower risk for pump thrombosis.

Event Description

Home inr monitor comparison: patient's home inr monitor read 2.1 and the lab result was 1.7.This difference is concerning because it means the difference in not changing the treatment plan (inr of 2.1) and treating the patient with lovenox and adjusting coumadin to lower risk for pump thrombosis.

• Brand Name: COAGUCHECK HOME METER
• Type of Device: TEST, TIME, PROTHROMBIN
• Manufacturer (Section D): ROCHE DIABETES CARE, INC.; 9115 hague road; indianapolis IN 46250
• MDR Report Key: 8013650
• MDR Text Key: 125290641
• Report Number: 8013650
• Device Sequence Number: 0
• Product Code: GJS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial,Followup
• Report Date: 10/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/16/2018
• Event Location: Home
• Date Report to Manufacturer: 10/29/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/29/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 26280 DA