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

Device Problem Nonstandard Device (1420)

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

Event Type  malfunction  

Event Description

This is a complaint about how a class 1 fda recall was handled by my health care provider.The fda recall handling i am reporting is the "roche diagnostics to replace coagucheks xs pt test strips" and is listed at https://www.Fda.Gov/safety/recalls/ucm626140.Htm.On that page it states "action required - health care providers: advise your self-testing pts to do the same." the mfr is roche diagnostics and my health care provider is (b)(6).I am a pt of (b)(6) and use a device listed in the recall.The recall date is listed as 10/31/2018 on the fda site: https:www.Fda.Gov/safety/recalls/.I was however not notified about the recall.I was made aware of the recall later when reporting a test result to (b)(6) on (b)(6) 2019.I have tried to get clear info from (b)(6) about why i was not timely and properly notified but have been met with conflicting and changing stories.In addition to email/online messages, i have had conversations with (b)(6) manager of anti-coagulation care service in (b)(6), and (b)(6) regional clinical services mgr, pharmacy, (b)(6) region.When requesting info from (b)(6) about why i was not notified about the recall, i was initially told by (b)(6) that they had sent me a letter notifying me about the recall.When requesting to get the info in writing, (b)(6) then changed their story and stated that they had in fact not sent me a letter - that a mistake had been made.When i voiced concern about other pts potentially also not being notified i was then told by (b)(6) that i was the only pt that had not been notified - all other pts had been sent a letter.I find (b)(6) handling of the class 1 fda recall worrying and peculiar in that they claim all of their pts were notified except one; worrying because they are changing that story about when and how i was and was not notified.This seems to indicate that (b)(6) either have no process in place or the process is insufficient to properly handle fda recalls.Fda safety report id# (b)(4).

• Brand Name: COAGUCHEK XS PT TEST STRIPS
• Type of Device: TEST, TIME, PROTHROMBIN
• Manufacturer (Section D): ROCHE DIAGNOSTICS OPERATIONS INC.
• MDR Report Key: 8509051
• MDR Text Key: 141968536
• Report Number: MW5085808
• 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: 04/09/2019

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/11/2019
• Type of Device Usage: N
• Patient Sequence Number: 1