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

Model Number 1229999

Device Problems Product Quality Problem (1506); High Readings (2459)

Patient Problem Test Result (2695)

Event Date 10/04/2018

Event Type  malfunction  

Event Description

I am a coaguchek patient.I received a letter in the mail that the test strips i have may not be good.My inr was high the last two weeks.I have called their 800 number that was on the letter for 3 days now and they do not call me back.I would appreciate any feedback from this.Roche diagnostics is the company that makes these strips.My name is (b)(6) email (b)(6).Thanks.

• Brand Name: COAGUCHEK
• Type of Device: TEST TIME PROTHROMBIN
• Manufacturer (Section D): ROCHE DIAGNOSTICS OPERATIONS, INC.
• MDR Report Key: 7947000
• MDR Text Key: 123369138
• Report Number: MW5080418
• 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: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 1229999
• Device Lot Number: 29415123
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 72 YR