MAUDE Adverse Event Report: ROCHE DIAGNOSTIC OPERATIONS INC COAGUCHEK TEST STRIPS; TEST, TIME, PROTHROMBIN

Lot Number 29494312

Device Problems Defective Device (2588); Device Displays Incorrect Message (2591)

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

Event Date 10/18/2018

Event Type  Injury  

Event Description

Inr registered over 6 on coaguchek test strips on (b)(6) 2018 and then in the 2 range only 2 days later.Continued to monitor with the strips and then in (b)(6) received error 4 message upon strip insertion for all the remaining 23 strips.Upon research, found out about recall on the internet.No notification from roche since then.I find this extremely disturbing; the negligence and cavalier attitude of roche toward those patients who home monitor is unacceptable.Fyi, i have used this lot of strips from (b)(6) onwards.I found it necessary to test 2-3 times per week to get inr in range after withholding warfarin.Then i find out that the strips are defective and chances are i have been out of range when withholding the warfarin.I have much to be thankful for this (b)(6) i.E.No stroke or clot.The delay in recall and lack of notification are indefensible.Roche needs to be held to higher standards.When i attempted to contact roche, i was placed on hold for approximately 15 minutes: so i in turn, filled this report.

• Brand Name: COAGUCHEK TEST STRIPS
• Type of Device: TEST, TIME, PROTHROMBIN
• Manufacturer (Section D): ROCHE DIAGNOSTIC OPERATIONS INC
• MDR Report Key: 8102121
• MDR Text Key: 128564753
• Report Number: MW5081603
• 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: 11/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2019
• Device Lot Number: 29494312
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 68 YR
• Patient Weight: 77