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

Catalog Number 03666794

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Dysphasia (2195); Numbness (2415)

Event Date 05/30/2018

Event Type  Injury  

Event Description

I tested my inr using my coaguchek xs meter (type 03666794) my result came back as a 4.7 which is out of range.The person who monitors my blood results recommended that i hold off on taking 2 doses.Which was 2 days of 5 mg of warfarin.I had a tia on (b)(6) 2018 while eating lunch and had my husband drive me to the emergency room.The tia lasted roughly 15-20 mins where my left half of my body started going numb and i started slurring.While in the ec they tested my blood and i came back about 1.2 for my inr.I was admitted for the night and had to stay through the next morning.

• Brand Name: COAGUCHEK XS
• Type of Device: TEST, TIME, PROTHROMBIN
• Manufacturer (Section D): ROCHE DIAGNOSTIC GMBH
• MDR Report Key: 7922357
• MDR Text Key: 122329525
• Report Number: MW5080217
• 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: 09/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 03666794
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/28/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 39 YR
• Patient Weight: 74