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 Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(manufacturer narrative = t, corrected data = f) (b)(4).Returned meter evaluated with no defect found.Test strips not returned for evaluation.Most likely underlying root cause of malfunction: user had an inaccurate reference.Note: unable to make contact with the customer via telephone at call back on 01/21/2017.At call back on (b)(6) 2017, the customer stated her condition had improved and she was not currently having any diabetic symptoms.The customer stated that no medical attention was needed since the last call.The customer stated that no additional blood tests were done using the meter.
Event or Problem Description
Consumer reported complaint for high blood glucose test results.Daughter is calling on behalf of the customer stating that new meter received this week is giving high readings.The customer is concerned with tests results from results obtained of 507 mg/dl.The customer's expected fasting blood glucose test result range is 170 - 200 mg/dl.During the call on (b)(6) 2017, the customer felt well and did not report any symptoms.Daughter stated customer's meter read 507 mg/dl fasting at 8:10 pm on (b)(6) 2017.Daughter stated the customer was taken to the hospital and at 9:00 pm her blood sugar meter result was 187 mg/dl and the lab result was 174 mg/dl.Daughter stated no intervention was received at the hospital and the customer was released.During the call on (b)(6) 2017, a back to back blood test was performed by the customer non-fasting and produced test results of 337 mg/dl using truetrack meter and 284 mg/dl using truetrack meter.The product is stored according to specification.The test strip lot manufacturer's expiration date is 12/15/2018 and open vial date is (b)(6) 2017.The meter memory was reviewed for previous test result history: (b)(6).Customer's daughter states that her (b)(6) mother usually refuses to take her medications and spits them out.

• 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: 6339095
• Report Number: 1000113657-2017-00325
• Device Sequence Number: 16403166
• Product Code: NBW
• UDI-Device Identifier: 00021292008888
• UDI-Public: (01)00021292008888(17)181215(10)RT4927
• 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): 02/17/2017

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: 12/15/2018
• Device Model Number: TRUETRACK
• Device Catalogue Number: A4H01-81
• Device Lot Number: RT4927
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2017
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2017
• Initial Report FDA Received Date: 02/17/2017
• 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