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

Model Number	TRUETRACK
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Codes	Fainting (1847); Hypoglycemia (1912); Blurred Vision (2137)
Date of Event	03/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Returned meter evaluated with no defect found.Returned test strips evaluated with defect found.Qc investigation on 3/27/2017 returned test strips produce low readings.(b)(4).Note: manufacturer contacted customer on 3/17/2017 in a follow-up call in order to ensure the customer's condition since the initial call; customer's condition worsened.He is tired and blurry vision, floating dark spot in right eye.No medical attention but customer states he will schedule appointment with opthlamologist that performed his previous eye surgery.
Event or Problem Description
Consumer reported complaint for erratic blood glucose test results.The customer is concerned with tests results from results obtained of 130 and 187mg/dl.The customer's expected fasting blood glucose test result range is 100 to 150mg/dl.The customer did report symptom of blurry vision.Medical attention is not reported as a result of the actual blood glucose results and reported symptoms.The product is stored according to specification.During the call on (b)(6) 2017, a back to back blood test was performed by the customer fasting and produced test results of 134 and 184mg/dl using true track meter.The test strip lot manufacturer's expiration date is 01/26/2019 and open vial date is (b)(6) 2017.The meter memory was reviewed for previous test result history: (b)(6).Customer reported complaint for erratic results.Customer states he has blurry vision but does not require medical attention due to results obtained.In (b)(6) 2017, customer suffered an episode of syncope and had to be taken to the hospital with a bgr: 25 mg/dl when paramedics arrived.Customer's meter read between 170-180 mg/dl.Customer's orders are to administer 1 u of fast-acting insulin for every 10 mg/dl over 130 mg/dl.He administered fast-acting accordingly, along with his standing order of 20 u of long-acting insulin.Customer had a kidney transplant on (b)(6) 2016 and his doctor wants customer to maintain his blood sugar no higher than 120 mg/dl.Shortly after administering fast-acting insulin customer passed out and his son called 911 and was taken to the hospital with a blood sugar level of 25 mg/dl.Customer states he was given, orange juice, iv fluids and something sublingual to bring his blood sugar level up and was released 6 hours later.

• 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: 6461726
• Report Number: 1000113657-2017-00623
• Device Sequence Number: 476291
• Product Code: NBW
• UDI-Device Identifier: 00052569132463
• UDI-Public: (01)00052569132463
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 04/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: TRUETRACK
• Device Catalogue Number: A4H01-81
• Device Lot Number: RT4954
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2017
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2017
• Initial Report FDA Received Date: 04/05/2017
• 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
• Outcome Attributed to Adverse Event: Hospitalization