MAUDE Adverse Event Report: ROCHE DIAGNOSTIC OPERATIONS INC COAGUCHEK TEST STRIPS (XS PT TEST) HOME TESTING OF INR LEVEL WHEN ON DAILY COUMD; TIME TEST PROTHROMBIN

Catalog Number 04625315

Device Problem Nonstandard Device (1420)

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

Event Date 01/15/2019

Event Type  malfunction  

Event Description

In re class 1 recall of coaguchek xs pt test strips ref web site.Https://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm624822.Htm?utm_campaign=2012019_pr_fda%20warns%20of%recall%20test%20strip%20devices%20used%20to%20monitor%20warfarin&utm_medium=email&utm_source=eloqua.I bought 48 of those strips (04625315160, lot 29494711).I submitted paperwork in (b)(6) 2019 by email and mail to (b)(4) (the agent roche is using to process requests to replace possibly faulty test strips).I have not heard back from (b)(4) or roche.This lack of timely processing by roche and associates might create a hardship for some innocent users of the strips as we have had to buy strips again at our expense.(b)(6).

• Brand Name: COAGUCHEK TEST STRIPS (XS PT TEST) HOME TESTING OF INR LEVEL WHEN ON DAILY COUMD
• Type of Device: TIME TEST PROTHROMBIN
• Manufacturer (Section D): ROCHE DIAGNOSTIC OPERATIONS INC
• MDR Report Key: 8386211
• MDR Text Key: 137977279
• Report Number: MW5084591
• 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: 02/28/2019

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: No Information
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: 04625315
• Device Lot Number: 29494711
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/01/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 84