MAUDE Adverse Event Report: ROCHE ROCHE; COAGUCHEK XS PRO

Lot Number 238, 206

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

We were using the coaguchek xs pro devices in our anticoagulation clinics for the past few years.In (b)(6) 2017, we noticed the coaguchek was no longer correlating with our main lab instrument, the stago compact within the clia acceptable limit of +/- 0.5 inr.We contacted roche and stago about the problem and investigated many pts and qc records with no answers.Roche insists the issue is the coaguchek and stago devices are so different from each other that they can't compare well.However, my 6 months method comparisons were fine before (b)(6) 2017.I discovered that any inr readings on the coaguchek greater than 3.0 did not correlated within the 0.5 inr to our main lab stago instrument.I had complaints from my pharmacists that they were changing coumadin dosage based on the coaguchek inr only to find out later that the lab draw was much different.This was leaving them in the position of having to adjust dosage again and confusing the pts.The coaguchek was only comparing well to the main lab up to an inr of 3.0.Anything greater than 3.0 was inconsistent across all devices, locations, pts and operators.Dates of use: (b)(6) 2013 - (b)(6) 2017.Diagnosis or reason for use: point of care inr for coumadin monitoring.

• Brand Name: ROCHE
• Type of Device: COAGUCHEK XS PRO
• Manufacturer (Section D): ROCHE
• MDR Report Key: 7276191
• MDR Text Key: 100463613
• Report Number: MW5075318
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/14/2018

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: Health Professional
• Device Lot Number: 238, 206
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/15/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1