MAUDE Adverse Event Report: TRIVIDIA HEALTH INC TRUE METRIX; SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER

Model Number	STRIP, RLN TMX 100CTMG/DL
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Meter and test strips were not returned for evaluation.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.Note: manufacturer contacted customer in a follow-up call to ensure the replacement products resolved the initial concern - unable to establish contact with customer at this time.
Event or Problem Description
Consumer reported complaint for high blood glucose test results.The customer is concerned with test results obtained of 241, 226, 243, 231 and 316 mg/dl.The customer¿s expected fasting blood glucose test result range is 110 - 150 mg/dl.The customer feels well and did not report any symptoms.Medical attention is not reported as a result of the actual blood glucose results.During the call, a back to back blood test was not performed by the customer.The customer was not using the correct test strips for the meter; customer was using true metrix relion test strips.The product is stored according to specification in the bedroom.The test strip lot manufacturer¿s expiration date is 03/25/2021 and open vial date is (b)(6) 2019.The meter memory was reviewed for previous test result history: result 1: 241mg/dl date: (b)(6) 2019 time: 01:07pm fasting.Result 2: 226mg/dl date: (b)(6) 2019 time: 09:17am fasting.Result 3: 243mg/dl date: (b)(6) 2019 time: 06:23am fasting.Result 4: 231mg/dl date: (b)(6) 2019 time: 11:10am fasting.Result 5: 316mg/dl date: (b)(6) 2019 time: 10:30am fasting.
Additional Manufacturer Narrative
Sections with additional information as of 20-feb-2020: h6: updated fda's method, result, and conclusion codes.H10: meter was not returned for evaluation.Test strips were not returned for evaluation.Retention testing was performed using test strips from the same lot.Retention strip lot tested and passed.Note: manufacturer contacted customer in a follow-up call to ensure the customer's products resolved the initial concern - able to establish contact with customer and stated product is working as intended.

• Brand Name: TRUE METRIX
• Common Device Name: SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER
• Manufacturer (Section D): TRIVIDIA HEALTH INC; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 9587605
• Report Number: 1000113657-2020-00025
• Device Sequence Number: 11663572
• Product Code: NBW
• UDI-Device Identifier: 00021292012236
• UDI-Public: (01)00021292012236
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 02/20/2020

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: 03/25/2021
• Device Model Number: STRIP, RLN TMX 100CTMG/DL
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MW3522S
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 12/17/2019
• Initial Date Received by Manufacturer: 12/17/2019
• Supplement Date Received by Manufacturer: 01/21/2020
• Initial Report FDA Received Date: 01/14/2020
• Supplement Report FDA Received Date: 02/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1