MAUDE Adverse Event Report: ROCHE DIAGNOSTICS OPERATIONS INC. COAGUCHEK XS PT TEST STRIPS; TEST, TIME, PROTHROMBIN

Model Number 04625374

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Memory Loss/Impairment (1958); Weakness (2145); Dysphasia (2195)

Event Date 09/21/2018

Event Type  Injury  

Event Description

Had a mini stroke, blood was too thick, backed up in heart chambers forming a blood clot.Dr.(b)(6), (b)(6) hospital "hospitalist".Took 5mg warfarin 10-15 mins before having mini stroke.On friday, (b)(6) 2018, facial droop, problems speaking, problems using right arm, left side weakness.Taken by ambulance to (b)(6) hospital, (b)(6).Symptoms still present at time in er, admitted to hospital; discharged (b)(6), improvement of symptoms overnight.Some memory issues to date.See onyx heart valve instructions, received notice to (b)(6), 4:34pm delivered (b)(6) to retest if inr #'s were high.This is the same day i was released from the hospital.Before coaguchek dosage for warfarin was mon.10mg, tues.5mg, wed.10mg, thurs.5mg, fri.5mg, sat.10mg and sun.5mg.While using coaguchek home testing system; high readings; dtr warfarin used based on high readings, mon.0mg, tues.5mg, wed.10mg, thurs.5mg, fri.5mg, sat.10mg and sun.5mg.I believe i am having some memory loss issues since the stroke.I believe the dosage amounts are accurate.

• Brand Name: COAGUCHEK XS PT TEST STRIPS
• Type of Device: TEST, TIME, PROTHROMBIN
• Manufacturer (Section D): ROCHE DIAGNOSTICS OPERATIONS INC.
• MDR Report Key: 8194411
• MDR Text Key: 131608899
• Report Number: MW5082545
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 12/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2019
• Device Model Number: 04625374
• Device Lot Number: 28632021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 0
• Treatment: COAGUCHEK XS REF# 04837738, GTIN# 04015630945689, (B)(4)
• Patient Outcome(s): Hospitalization; Life Threatening; Other
• Patient Age: 63 YR
• Patient Weight: 115