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

Model Number TRUETRACK

Device Problem Low Test Results (2458)

Patient Problems Angina (1710); Dizziness (2194)

Event Date 01/07/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Product not yet returned for evaluation.Most likely underlying root cause: mlc-58-user had an inaccurate reference: self: the person is using themselves as the reference or how they feel at the time they run the blood test.Test strips udi# (b)(4).Manufacturer contacted customer (several attempts) in a follow-up call to ensure that the replacement products resolved the initial concern - unable to establish contact with the customer at this time.Product notification letter sent to customer to contact customer care.

Event Description

Consumer reported complaint for low blood glucose test results accompanied by symptoms.The customer is concerned with all tests results obtained.The expected fasting blood glucose test result range is the upper 300's to 400's mg/dl.The customer had no symptoms at the time of the call.Medical attention is reported on a previous event as a result of the actual blood glucose results and symptoms of dizziness and chest pain.The product is stored according to specification in the bedroom.During the call on (b)(6) 2018, a blood test was not performed by the customer.The test strip lot manufacturer's expiration date is 2/28/2021 and open vial date is 2-3 weeks ago.The meter memory was reviewed for previous test result history: (b)(6).Customer states that meter is giving him low results compared to a1c.Customer states that blood sugar runs high, but meter is reading low normally in the upper 300's and 400's.Customers sates that his last a1c was 12.5 done 2 months ago.On (b)(6) 2019, customer stated that he was feeling dizzy early in the morning and woke up and took his blood glucose and the result came back as 144 mg/dl fasting.Customer stated that he ended up going to the er where they took his blood glucose and it was 217 mg/dl fasting when he went to the hospital.Customer was not admitted but was given iv fluids and treated with ativan rx.He was released the same day.Customer didn't received any medication for his blood glucose.Customer stated that per his paperwork from the hospital, it stated, chest pain due to unknown source and advised to follow-up with his primary care doctor.Customer is feeling fine right now and no further medical attention is required.

• Brand Name: TRUETRACK
• 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: 8292782
• MDR Text Key: 136990125
• Report Number: 1000113657-2019-00080
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00021292007638
• UDI-Public: (01)00021292007638
• Combination Product (y/n): N
• PMA/PMN Number: K032657
• 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: 01/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: TRUETRACK
• Device Catalogue Number: A4H01-81
• Device Lot Number: RV5298
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Home
• Date Manufacturer Received: 01/07/2019
• 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