MAUDE Adverse Event Report: TRIVDIA HEALTH TRUE METRIX; BLOOD GLUCOSE TEST STRIPS

Model Number VARIOUS

Device Problem Invalid Sensing (2293)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/20/2017

Event Type  malfunction  

Event Description

I am a type 2 diabetic, i test for glucose levels using the true metrix strips manufactured by trivida health of (b)(6).The test level varies considerably more than the stated percentage in the package insert.Today the levels tested within minutes were 203, 282, 212, 246.These levels dictate the amount of insulin i take and could result in an overdose.I have tested multiple times on various other days with similar results.Is the product compounded: yes.Is the product over-the-counter: no.

• Brand Name: TRUE METRIX
• Type of Device: BLOOD GLUCOSE TEST STRIPS
• Manufacturer (Section D): TRIVDIA HEALTH; ft. lauderdale FL
• MDR Report Key: 6662999
• MDR Text Key: 78380431
• Report Number: MW5070590
• Device Sequence Number: 1
• Product Code: NBW
• 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: 06/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 08/08/2018
• Device Model Number: VARIOUS
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/21/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 75 YR
• Patient Weight: 103