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

Model Number	METER, AIR TVH TMX NFRSMG/DL
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	Weakness (2145)
Date of Event	02/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Meter and test strips were not returned for evaluation.Most likely underlying root cause: mlc-62: user had poor technique.Note: manufacturer contacted customer in a follow-up call to ensure that the customer's condition improved - unable to establish contact with customer at this time.No product notification letter sent since no customer address on file.Note: customer reported another device used in this event and it is reported in case (b)(4).Report 2 of 2.
Event or Problem Description
Consumer reported complaint for e-0 accompanied by symptom.Daughter is calling on behalf of the customer.The expected fasting blood glucose test result range is undisclosed.The customer did report symptoms of slurred speech and feeling weak.Medical attention is not reported as a result of the actual blood glucose results.The product is stored according to specification in the basement area.During the call a blood test was not performed by the customer.The test strip lot manufacturer¿s expiration date is 04/26/2020 and open vial date is 2/11/2020.The meter memory was not reviewed for previous test result history.
Additional Manufacturer Narrative
Sections with additional information as of (b)(6) 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: customer reported another device used in this event and it is reported in case (b)(4).Report 2 of 2.

• Brand Name: TRUE METRIX AIR
• 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: 9811073
• Report Number: 1000113657-2020-00144
• Device Sequence Number: 643002
• Product Code: NBW
• UDI-Device Identifier: 00021292007447
• UDI-Public: (01)00021292007447
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K150052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/26/2020
• Device Model Number: METER, AIR TVH TMX NFRSMG/DL
• Device Catalogue Number: REA4H01-01
• Device Lot Number: MV2968S
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/11/2020
• Initial Date Received by Manufacturer: 02/11/2020
• Supplement Date Received by Manufacturer: 03/27/2020
• Initial Report FDA Received Date: 03/10/2020
• Supplement Report FDA Received Date: 03/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other