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

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

Patient Problems Chest Pain (1776); Myocardial Infarction (1969); Pain (1994); Reaction (2414); Neck Pain (2433)

Event Date 10/07/2018

Event Type  Injury  

Event Description

I have been using coaguchek xs system since (b)(6) 2017.My dr has been adjusting my warfarin according to the readings on this system.On (b)(6) 2018, i called an ambulance because of chest, arm and neck pain.It was found that i was having a heart attack.I was taken to the cath lab and had 2 stents put in.My inr was 1.8, before the stents were put in.It should have been between 2-3 for a safe range with my warfarin dosage.They deemed that low enough to do the cath safely.I was put on a second blood thinner and had a severe reaction to it after discharge from the hospital.The reaction required me to have more tests.Echocardiogram, lab tests, dr visits, etc.Since the heart attack, my atrial fibrillation has worsened and i have to take more medicine.I become short of breath, tired, dizzy, and have difficulty sleeping.I am now on two blood thinners.I bruise easily.A blood vessel broke in my eye.I am in fear of falling because of all the meds i am now on.The company that supplies the testing strips sent me more strips and said they were calibrated correctly.I called them and told them i thought the readings were still too high after i took a test.They said they would send me new strips.I tested myself again with their strips yesterday, (b)(6) 2019 and the reading was 2.8.I took an inr test at the hosp that same day and their results were 2.3.Their strips are still defective.The new strips have arrived but i do not feel safe using them.I think the defective strips giving inaccurate readings and the results of warfarin changes caused my heart attack.I do not feel safe using their testing device.I wonder how many others have had strokes or heart attacks because of their defective strips.I read that they knew the strips were defective but they didn't tell me to stop using them.If they had i would have gone to a lab and been tested and saved myself from having a heart attack.My dr was shocked that i had a heart attack while on warfarin.

• Brand Name: COAGUCHEK
• Type of Device: TEST, TIME, PROTHROMBIN
• Manufacturer (Section D): ROCHE DIAGNOSTICS GMBH
• MDR Report Key: 8228036
• MDR Text Key: 132546708
• Report Number: MW5082926
• 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: 01/04/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• 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): Hospitalization; Life Threatening; Disability
• Patient Age: 78 YR
• Patient Weight: 86