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

Model Number	TRUETRACK
Medical Device Problem Code	Incorrect Or Inadequate Test Results (2456)
Health Effect - Clinical Codes	Weakness (2145); Dizziness (2194)
Date of Event	12/31/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(manufacturer narrative = t, corrected data = f) internal report # (b)(4).Product not yet returned for evaluation.Most likely underlying root cause of malfunction: user had an inaccurate reference.Note: at the follow-up call on (b)(6) 2017, the customer stated her condition had improved and she was not currently having any diabetic symptoms.The customer stated that she had gone to the hospital within a half hour of the initial call on (b)(6) 2016 and had her blood test taken.The customer stated that no other medical treatment was given, they had only taken her blood sugar.The customer stated that the diagnosis from the hospital was that her blood sugar was fine.The customer stated her blood sugar taken at the hospital was 84 mg/dl.The customer stated she left the hospital the same day ((b)(6) 2016) and was only at the hospital for four hours.The customer stated that no new medications or healthcare program had been suggested by healthcare professionals.The customer stated she did not perform any other blood test with the alleged defective device.
Event or Problem Description
Consumer reported complaint for erratic blood glucose test results.The customer is concerned with tests results from back to back blood tests of 107, 128 and 105 mg/dl.The customer's expected fasting blood glucose test result range is 90 - 110 mg/dl.During the call on (b)(6) 2016, the customer stated she felt weak and a little dizzy.The customer stated she had not eaten and wanted to go to the hospital to make sure her glucose levels were ok.The customer stated that she is pre-diabetic and has been monitoring her glucose levels for a few years.During the call on (b)(6) 2016, a back to back blood test was not performed as the customer stated she has bought and wasted so many strips and had no more.The product is stored according to specification.The test strip lot manufacturer's expiration date is 08/31/2018 and open vial date at time of call is a month ago.The meter memory was reviewed for previous test result history: 105mg/dl (b)(6) 2016 03:01 pm fasting: yes; 126mg/dl (b)(6) 2016 02:59 pm fasting: yes; 107mg/dl (b)(6) 2016 02:27 pm fasting: yes; 128mg/dl (b)(6) 2016 02:27 pm fasting: yes; 19mg/dl (b)(6) 2016 01:56 pm fasting: yes.Memory concerns:126mg/dl.Patient stated she hasn't eaten and want to go to the hospital to make sure her glucose levels are ok.Customer stated that she is pre-diabetic and has been monitoring her glucose levels for a few years.She states her results are inconsistent when she performed her own back to back testing while fasting.Customer stated she has bought and wasted so many strips and has no more and can't perform a back to back test at this time.She will seek medical attention after this call to see what her readings are.

• 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: 6282455
• Report Number: 1000113657-2017-00132
• Device Sequence Number: 1564211
• Product Code: NBW
• UDI-Device Identifier: 00021292008888
• UDI-Public: (01)00021292008888(17)180831(10)RT4886
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 01/27/2017

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 Expiration Date: 08/31/2018
• Device Model Number: TRUETRACK
• Device Catalogue Number: A4H01-81
• Device Lot Number: RT4886
• 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: 12/31/2016
• Initial Report FDA Received Date: 01/27/2017
• 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