MAUDE Adverse Event Report: ROCHE COAGUCHECK INR MONITOR

Device Problems Device Operates Differently Than Expected (2913); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Test Result (2695)

Event Date 01/02/2018

Event Type  malfunction  

Event Description

Patient was using coagucheck home inr monitoring.She's had stable inr levels for 2 years using stable dose of warfarin.After a battery change for the device, her inr became very low and with increased doses of warfarin, the inr did not increase.After multiple calls to the mfr, the patient's husband was informed that after battery change the device defaults to an european non inr monitoring value that doesn't correlate to inr.It was found that the corrected inrs were supertherapeutic and could have led to serious bleeding or other issues.Patient was the recipient of an avr which requires warfarin to be therapeutic for proper protection of stroke.During the time of the falsely low inrs, the patient was transitioned to an unstudied anticoagulant with the hope that it would provide better stroke protection.

• Brand Name: COAGUCHECK INR MONITOR
• Type of Device: INR MONITOR
• Manufacturer (Section D): ROCHE
• MDR Report Key: 7316991
• MDR Text Key: 101771501
• Report Number: MW5075700
• Device Sequence Number: 0
• Product Code: GJS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 03/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 80 YR
• Patient Weight: 65