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

Model Number	TRUETRACK
Medical Device Problem Codes	Incorrect Or Inadequate Test Results (2456); Low Test Results (2458)
Health Effect - Clinical Codes	Hypoglycemia (1912); Dizziness (2194)
Date of Event	05/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report # (b)(4).Returned meter and returned test strips evaluated with no defects found.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 strip udi# (b)(4).Note: after several attempts manufacturer contacted customer on (b)(6) 2017 in a follow-up call in order to ensure the customer's condition since the initial call; customer advised that she has been hospitalized since (b)(6) 2017 (day of the call).She is currently in icu.Her diagnosis is for hypoglycemia.Her blood glucose result at the hospital was 18mg/dl.Customer think she will be discharged today (b)(6) 2017.Another call back was made on (b)(6) 2017; customer condition improved.No medical attention needed at the time of the call.Customer satisfied with the replacement product.Customer states that she was released from the hospital on (b)(6) 2017.
Event or Problem Description
Consumer reported complaint for low and erratic blood glucose test results.The customer is concerned with the results obtained of 37 and 212mg/dl.The expected fasting blood glucose test result range is 170 to 180mg/dl.The customer feels well and did not report any symptoms.Medical attention is reported as a result of the actual blood glucose results.The product is stored by customer 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 45 and 38mg/dl using true track meter.The test strip lot manufacturer's expiration date is 04/30/2019 and open vial date is 5/23/2017.The meter memory was reviewed for previous test result history (date / time not set): the 52mg/dl (b)(6) 2017 11:03 am fasting: yes, the 37mg/dl (b)(6) 2017 09:47 am fasting: yes, the 82 mg/dl (b)(6) 2017 09:42 am fasting: yes, the 50mg/dl (b)(6) 2017 09:40 am fasting: yes, the 212mg/dl (b)(6) 2017 09:40 am fasting: yes.Memory concerns: customer concerned with reading on (b)(6) 2017 of 212mg/dl.The customer called with concerns regarding their meter reading erratic.Their normal fasting glucose range is 170mg/dl to 180mg/dl.The customer denies the need for medical attention at the time of call.The customer is having any signs or symptoms of hypoglycemia at the time of call.The husband was repeating blood glucose test on the same finger each time.The customer had still not eaten anything since the night before.She did take 2 glucose tablets after obtaining a result of 37mg/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: 6661966
• Report Number: 1000113657-2017-01074
• Device Sequence Number: 10818014
• Product Code: NBW
• UDI-Device Identifier: 00041220842438
• UDI-Public: (01)00041220842438
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 06/22/2017

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: TRUETRACK
• Device Catalogue Number: A4H01-81
• Device Lot Number: RT5034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2017
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2017
• Initial Report FDA Received Date: 06/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization