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

Model Number	TRUETRACK
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	Dizziness (2194)
Date of Event	08/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report # (b)(4).Returned meter evaluated with no defect found.Test strips not returned for evaluation.Most likely underlying root cause: mlc-25-strip inserted backwards or upside-down test strip udi# (b)(4).Note: manufacturer contacted customer in several follow-up calls in order to ensure the customer's condition since the initial call.At the call back on (b)(6) 2017, customer reported still feeling a little dizzy and wobbly.No medical attention had been needed since the initial call.At call back on (b)(6) 2017, the customer was feeling much better and did not currently have any diabetic symptoms.Wife stated as customer is a new diabetic, she did contact the physician because of his symptoms and that the doctor is aware of what is happening with her husband.The doctor also advised her to follow the course of medication he is on.
Event or Problem Description
Consumer reported complaint for dead meter.Wife is calling on behalf of the customer.The meter did not turn on by inserting a test strip.When the s button was manually pressed, the meter would turn on and the averages would display.The customer's expected blood glucose test result range was undisclosed.At the time of the call on (b)(6) 2017, the customer reported feeling a little dizzy; customer had not eaten in four hours.The test strip lot manufacturer's expiration date is 04/14/2019 and open vial date is (b)(6) 2017.During the call, wife stated she had another vial of strips, lot# rt4944, expiration date of 01/13/2019; customer inserted a test strip into the meter and code 4944 appeared and went to the blood drop.Customer then performed a blood test and obtained a result of 148 mg/dl fasting using truetrack meter.The product is stored according to specification.The meter memory was not reviewed for previous test result history.

• Brand Name: TRUETRACK
• Common Device Name: BLOOD GLUCOSE SYSTEM
• Manufacturer (Section D): TRIVIDIA HEALTH, INC.; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 6828509
• Report Number: 1000113657-2017-01631
• Device Sequence Number: 10779515
• Product Code: NBW
• UDI-Device Identifier: 00050428264706
• UDI-Public: (01)00050428264706
• Combination Product (Y/N): N
• Initial Reporter State: MI
• PMA/510(K) Number: K032657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 08/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/14/2019
• Device Model Number: TRUETRACK
• Device Catalogue Number: A4H01-81
• Device Lot Number: RT5015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2017
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2017
• Initial Report FDA Received Date: 08/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1