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

Model Number	TRUETRACK
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Codes	Headache (1880); Dizziness (2194); Shaking/Tremors (2515)
Date of Event	03/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(manufacturer narrative = t, corrected data = f) (b)(4).Product not yet returned for evaluation.Most likely underlying root cause: mlc-134- user has low glucose value.Test strip (b)(4).Note: at follow-up call on 03/20/2018, the customer's condition had improved and she did not currently have any diabetic symptoms.No medical attention was needed since the last call.Customer had tested using the truetrack meter and had obtained result of 89 mg/dl fasting.At call back on (b)(6) 2018, the customer and her daughter stated that on (b)(6) 2018, customer had obtained a blood glucose test result of 68 mg/dl fasting using the alleged defective truetrack meter.Customer stated she was shaking and had called her doctor.The doctor had told her to not take her medication (diabetic pill).Customer reported no diabetic symptoms at time of call back and no further medical attention had been needed.
Event or Problem Description
Consumer reported complaint for low blood glucose test results.The customer is concerned with tests results from fasting back to back blood tests performed during the call of 58 and 88 mg/dl using truetrack meter.The customer's expected fasting blood glucose test result range is 80 - 100 mg/dl.At the time of the call on (b)(6) 2018, the customer reported symptoms of headache, dizzy and sweaty; medical attention was not needed at time of call.The product is stored according to specification in the living room.The test strip lot manufacturer's expiration date is 05/21/2020 and open vial date is (b)(6) 2018.The meter memory was reviewed for previous test result history (date/time not set; unable to verify more than two memory results): result 1 :69 mg/dl date: (b)(6) 2018 time: 11:55 am fasting.Result 2 :88 mg/dl date: (b)(6) 2018 time: 02:25 pm fasting.Customer called stating her blood sugar is reading lower than normal on this meter.Customers regular fasting range is 80-100 mg/dl.Customer states her meter read 69 mg/dl fasting.Customer is feeling symptoms of low blood sugar.Unable to verify more than 2 results on the meters memory.While doing the back to back test, the meter read a 30 point difference and gave an erratic result on the same hand, different finger.

• 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: 7412436
• Report Number: 1000113657-2018-00423
• Device Sequence Number: 19202988
• Product Code: NBW
• UDI-Device Identifier: 00021292009281
• UDI-Public: (01)00021292009281
• 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): 04/10/2018

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: 05/21/2020
• Device Model Number: TRUETRACK
• Device Catalogue Number: A4H01-81
• Device Lot Number: RU5202
• 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: 03/19/2018
• Initial Report FDA Received Date: 04/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1