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

Model Number	TRUEMETRIX
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not returned for evaluation.Customer declined replacement product at this time.Most likely underlying root cause: mlc-18- user has high glucose value test strip udi# (b)(4).Manufacturer contacted customer on (b)(6) 2018 in a follow-up call; customer did not need a replacement meter or strips his refused.Customer states that the meter and strips are working well no assistance needed.They have not had any medical intervention since the last call.
Event or Problem Description
Consumer reported complaint for hi blood glucose results.The expected fasting blood glucose test result range is unknown.The customer feels well and did not report symptoms.Medical attention is not reported as a result of the actual blood glucose results.The product is not stored by customer according to specification in the bathroom.During the call on (b)(6) 2018, a blood test was performed fasting by the customer and produced test results of hi mg/dl using true metrix meter.The test strip lot manufacturer's expiration date is 5/24/2019 and open vial date is (b)(6) 2018.The meter memory was reviewed for previous test result history: (date/time not stored correctly): result 1: hi, date:(b)(6), time: 7:15 pm, fasting.Result 2: hi, date:(b)(6), fasting.Customer did not have his old meter, so his wife bought this meter and they brought it home and did 2 blood tests.Each results read hi fasting with no symptoms.He had not taken his insulin and it was about 5-6 hours after eating his lunch.The customer and wife called to inquire about the hi result.I explained that the meter reads hi if blood glucose results are over 600 mg/dl.The wife, who is not a diabetic, ran her blood and it read 126 mg/dl.We offered to replace the meter and strips but the wife said he will take his insulin and if they want to have the meter replaced will call back.

• Brand Name: TRUEMETRIX
• Common Device Name: BLOOD GLUCOSE SYSTEM
• Manufacturer (Section D): TRIVIDIA HEALTH, INC.; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 7391891
• Report Number: 1000113657-2018-00390
• Device Sequence Number: 19118667
• Product Code: NBW
• UDI-Device Identifier: 00052569138557
• UDI-Public: (01)00052569138557
• Combination Product (Y/N): N
• PMA/510(K) Number: K140100
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/03/2018

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 Model Number: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MU2691
• 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: 03/08/2018
• Initial Report FDA Received Date: 04/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1