MAUDE Adverse Event Report: ROCHE DIAGNOSTICS GMBH COAGUCHEK XS; TEST, TIME, PROTHROMBIN

Model Number 04837738 001

Device Problem Nonstandard Device (1420)

Patient Problem No Code Available (3191)

Event Date 02/09/2018

Event Type  Injury  

Event Description

I have been well managed on warfarin for 23 years.As a health care provider myself i have been able to manage my dosing for all of those years.I started using a coaguchek device to test inr in (b)(6) 2017.Starting in (b)(6) 2018 my inr became very erratic.My md and i were at a loss.Just learned that roche maker of device, had recalled test strips 07/2018 and expanded recall to include my strips in 11/2018.By not informing me sooner they put me in grave danger.They had my data and that of many others but apparently did not analyze it to look for potential victims.If they had inquired they would have discovered the problem much earlier.Further their response to problem has been egregious.I just received only 6 replacement test strips, not enough to do the more frequent testing i need to do to properly adjust my dose.

• Brand Name: COAGUCHEK XS
• Type of Device: TEST, TIME, PROTHROMBIN
• Manufacturer (Section D): ROCHE DIAGNOSTICS GMBH
• MDR Report Key: 8106198
• MDR Text Key: 128580254
• Report Number: MW5081618
• 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: 11/24/2018

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: No Information
• Device Model Number: 04837738 001
• Device Lot Number: 05706124
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/26/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other
• Patient Age: 63 YR
• Patient Weight: 70