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

Model Number UNKNOWN

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Sensing Problem (2917)

Patient Problem Obstruction/Occlusion (2422)

Event Date 11/14/2018

Event Type  Injury  

Event Description

I have been using coaguchek xs pt test strips for patient self-testing.Was hospitalized on (b)(6) 2018 due to a blood clot on my artificial heart valve.I have been using the strips for 10 years.On (b)(6) 2018 i had a reading of 1.1.On (b)(6) 2018 i had a reading of (8.0 plus) on the test strip.So the coag clinic had me stop my warfarin and then went to clinic for testing and it was very low (1.1).My normal numbers are to be 2.0 to 3.0.The doctor decided to do a echo and found that i had a clot on my artificial valve.They sent me to er and i ended up spending a week in the hospital on tpa to dissolve the clot on my valve.Thank you (b)(6).

• Brand Name: COAGUCHEK XS PT TEST STRIPS
• Type of Device: TEST, TIME, PROTHROMBIN
• Manufacturer (Section D): ROCHE DIAGNOSTICS OPERATIONS INC
• MDR Report Key: 8102075
• MDR Text Key: 128556068
• Report Number: MW5081599
• 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: 11/21/2018

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNWON
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/23/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 65 YR
• Patient Weight: 79