MAUDE Adverse Event Report: ROCHE DIAGNOSTICS OPERATIONS, INC. COUGUCHEK ; TEST, TIME, PROTHROMBIN

Model Number XS

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Displays Incorrect Message (2591)

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

Event Date 05/20/2020

Event Type  malfunction  

Event Description

I was using coagucheck by roche to test my inr.I've had multiple instances where i can't get a result; 4 test strips and multiple error codes on today's attempt.I've had the same issues in the past where i've used up to 7 strips for 1 result.Concerned the results i'm getting aren't accurate at all.If it's taking so many strips why is just 1 working ok? fda safety report id# (b)(4).

• Brand Name: COUGUCHEK
• Type of Device: TEST, TIME, PROTHROMBIN
• Manufacturer (Section D): ROCHE DIAGNOSTICS OPERATIONS, INC.
• MDR Report Key: 10086659
• MDR Text Key: 192148227
• Report Number: MW5094647
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/20/2020
• 4 Devices were Involved in the Event: 1 2 3 4

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
• Device Model Number: XS
• Device Catalogue Number: 04837738
• Device Lot Number: 04015630945689
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/22/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Weight: 99