MAUDE Adverse Event Report: ROCHE DIAGNOSTICS GMBH COAGUCHEK VANTAS METER WITH XS TEST STRIPS; SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER

Model Number VANTAS METER

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

Patient Problem Test Result (2695)

Event Date 11/01/2018

Event Type  Injury  

Event Description

I tested my inr two ways within 30 minutes of each other: i tested at (b)(6) hospital with a result of 2.3 ((b)(6) 2018); i tested using my roche diagnostics.Vantas meter with xs strips with a result of 2.1 ((b)(6) 2018).Note: the two tests were 30 minutes apart with no food or alcohol consumption between tests.Having an inaccurate machine is life threatening because of bleeding and stroke risk.

• Brand Name: COAGUCHEK VANTAS METER WITH XS TEST STRIPS
• Type of Device: SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER
• Manufacturer (Section D): ROCHE DIAGNOSTICS GMBH
• MDR Report Key: 8070784
• MDR Text Key: 127334730
• Report Number: MW5081243
• 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: 11/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: VANTAS METER
• 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): Life Threatening
• Patient Age: 31 YR
• Patient Weight: 68