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	09/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Meter and test strips were not returned for evaluation.Most likely underlying root cause: mlc-101: user used the wrong strip note: manufacturer contacted customer in a follow-up call on 13-oct-2020 to ensure the replacement products resolved the initial concern - able to establish contact with customer and stated replacement product resolved initial concern.
Event or Problem Description
Consumer reported complaint for high blood glucose test results.The customer is concerned with tests results obtained of 185 and 146mg/dl.The expected fasting blood glucose test result range is 120mg/dl.The customer did not report symptoms.Medical attention is not reported as a result of the actual blood glucose results.The product is stored according to specification in the dining room.During the call a blood test was not performed by the customer (wrong strips).The test strip lot manufacturer¿s expiration date is 11/30/2021 and open vial date is one week ago.The meter memory was reviewed for previous test result history.(b)(6).
Additional Manufacturer Narrative
Sections with additional information as of 06-dec-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.Most likely underlying root cause updated from "mlc-101: user used the wrong strip¿ to "mlc-055 user had poor technique-inaccurate reference".

• 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: 10747811
• Report Number: 1000113657-2020-00784
• Device Sequence Number: 11689690
• Product Code: NBW
• UDI-Device Identifier: 00021292012236
• UDI-Public: (01)00021292012236
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2020

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: 11/30/2021
• Device Model Number: STRIP, RLN TMX 100CTMG/DL
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MX4321S
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 09/30/2020
• Initial Date Received by Manufacturer: 09/30/2020
• Supplement Date Received by Manufacturer: 11/24/2020
• Initial Report FDA Received Date: 10/28/2020
• Supplement Report FDA Received Date: 12/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1