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

Lot Number 27216421

Device Problem High Test Results (2457)

Patient Problems Headache (1880); Weakness (2145); Test Result (2695)

Event Date 08/01/2018

Event Type  Injury  

Event Description

My inr tested 4.1 was too elevated, over 3.0 is too elevated.The strips came, told me to discard any affected test strips.When my inr was elevated, i get weak, headaches.I go to bed.Stop medication for two days.Tested my inr again, i am not able to go anywhere.This has been going on since (b)(6) 2018 - (b)(6) 2018.The test strips are by coaguchek - roche diagnostics.I didn't know i was getting affected test strips.I can't take any thing for my headache's because my dvr would be elevated more.

• Brand Name: COAGUCHEK
• Type of Device: TEST, TIME, PROTHROMBIN
• Manufacturer (Section D): ROCHE DIAGNOSTICS GMBH
• MDR Report Key: 8208589
• MDR Text Key: 132104097
• Report Number: MW5082737
• 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: 12/31/2018
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2019
• Device Lot Number: 27216421
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 87 YR
• Patient Weight: 54