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

Model Number	TRUETRACK
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Codes	Fatigue (1849); Weakness (2145)
Date of Event	03/29/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not returned for evaluation.Customer declined replacement product at this time.Most likely underlying root cause of malfunction: user applied blood to strip before inserting strip into meter.(b)(4).Note: manufacturer contacted customer on 3/29/2017 in a follow-up call in order to ensure the customer's condition since the initial call; customer's condition had improved and he was not currently having any diabetic symptoms.Wife had taken customer to the er on (b)(6) 2017.The diagnosis was high blood sugar and low magnesium.The customer was administered insulin and magnesium injections.The customer's blood glucose test result when at the er was 325 mg/dl.The customer was not admitted and returned home on the same day.The customer will see his primary doctor on (b)(6) 2017 for follow-up.The customer stated no additional blood tests were performed with the alleged defective device.
Event or Problem Description
Consumer reported complaint of e-3 error: used test strip, test strip outside of vial too long, sample on top of test strip.Wife is calling on behalf of the customer.The e-3 error message occurred when the blood sample was absorbed.Customer's wife explained they were placing the strip in the meter, applying the blood and then pushing the strip all the way in.The customer's expected blood glucose test result range was undisclosed.During the call on (b)(6) 2017, the customer reported feeling weak and tired.During the call on (b)(6) 2017, a blood test was performed by the customer non-fasting and produced test result of 486 mg/dl using truetrack meter.The product is not stored according to specification and is stored in the bathroom.The test strip lot manufacturer's expiration date is 12/14/2018 and open vial date is (b)(6) 2017.The meter memory was not reviewed for previous test result history.Wife calling for customer who is (b)(6) and was hospitalized last week for respiratory problems and diagnosed with copd.Advised customer's wife to call doctor or take husband to er because he is feeling weak and tired and it may not be related to his hospitalization since his bgr on the call was 486 mg/dl.

• 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: 6513355
• Report Number: 1000113657-2017-00715
• Device Sequence Number: 623970
• Product Code: NBW
• UDI-Device Identifier: 00087701405570
• UDI-Public: (01)00087701405570
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 04/21/2017

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: 12/14/2018
• Device Model Number: TRUETRACK
• Device Catalogue Number: A4H01-81
• Device Lot Number: RT4926
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2017
• Initial Report FDA Received Date: 04/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SECOND THERAPY