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

Catalog Number 03666794

Device Problem Incorrect Measurement (1383)

Patient Problem Thrombosis (2100)

Event Date 08/30/2018

Event Type  Injury  

Event Description

Bilateral dvt¿s lower extremities.Hospitalization required.Problem likely associated with inaccurate inr measurements using roche coaguchek self-testing meter and test strips.Treatment involved switching from warfarin to rivaroxaban.

• Brand Name: COAGUCHEK XS COAGULATION METER WITH COAGUCHEK XS PT TEST STRIPS
• Type of Device: TEST, TIME, PROTHROMBIN
• Manufacturer (Section D): ROCHE DIAGNOSTICS OPERATIONS, INC.
• MDR Report Key: 8202793
• MDR Text Key: 131892820
• Report Number: MW5082651
• 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: 12/26/2018

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: No Information
• Device Catalogue Number: 03666794
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/27/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 77 YR
• Patient Weight: 73