MAUDE Adverse Event Report: TRIVIDIA HEALTH, INC. TRUERESULT; BLOOD GLUCOSE SYSTEM

Model Number TRUERESULT

Device Problem Shelf Life Exceeded (1567)

Patient Problem Shaking/Tremors (2515)

Event Date 02/06/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Product not yet returned for evaluation.Most likely underlying root cause of malfunction: user had poor technique.Note: customer states she believes her symptoms are due to her not taking her seizure medication that morning.Manufacturer contacted customer (several attempts) in a follow-up call in order to ensure the customer's condition since the initial call - unable to establish contact with the customer at this time.

Event Description

Consumer reported complaint for meter issues and blood glucose test results.Customer was unable to get a blood glucose reading.The customer's expected fasting blood glucose test result range is undisclosed.The customer reports symptom of feeling shaky.Medical attention is not reported as a result of the actual blood glucose results and reported symptoms.The product is storage location is undisclosed.During the call on date, a blood test was performed by the customer fasting and produced test result of 102mg/dl using true result meter.The test strip lot manufacturer's expiration date is 03/19/2015 and open vial date is undisclosed.Customer was using expired strips.Customer states she believes her symptoms are due to her not taking her seizure medication in the morning.

• Brand Name: TRUERESULT
• Type of Device: BLOOD GLUCOSE SYSTEM
• Manufacturer (Section D): TRIVIDIA HEALTH, INC.; 2400 nw 55th court; fort lauderdale FL 33309
• Manufacturer Contact: karen devincent ; 2400 nw 55th court; fort lauderdale, FL 33309 ; 954677-920
• MDR Report Key: 6374303
• MDR Text Key: 68980810
• Report Number: 1000113657-2017-00420
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• PMA/PMN Number: K080641
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 03/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: TRUERESULT
• Device Catalogue Number: E4H01-81
• Device Lot Number: TN2713
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Home
• Date Manufacturer Received: 02/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SECOND THERAPY