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

Lot Number 29415123

Device Problem High Test Results (2457)

Patient Problem Test Result (2695)

Event Date 10/29/2018

Event Type  Injury  

Event Description

Inr testing date (b)(6) 2018 per doctor office instructions with home inr monitoring (alere).Home test strip result 4.5 using test strip lot #29415123.Went to hosp, lab result 3.5, therefore instructions were to keep same dosage as had been on.

Event Description

Add'l info rec'd from reporter on 02/13/2019 for report number mw5081132: reporter stated that she took her inr test and the result was 4.7 and she took her test again in a little while and it was 4.5.She was told to take coumadin and go to the lab in the morning and the test result was 2.6.She said her doctor told her to inject lovenox if her inr is below 3.The treatment has been withheld based on the result she rec'd.Her doctor told her to go back to the lab on (b)(6) 2019 for follow up.Other#: (b)(4).

• Brand Name: COAGUCHEK XS PT TEST STRIP
• Type of Device: TEST, TIME, PROTHROMBIN
• Manufacturer (Section D): ROCHE DIAGNOSTICS GMBH; 9115 hague road; indianapolis IN 46250
• MDR Report Key: 8046468
• MDR Text Key: 126664584
• Report Number: MW5081132
• 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,Followup
• Report Date: 02/13/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2019
• Device Lot Number: 29415123
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 62 YR
• Patient Weight: 65