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

Model Number	STRIP, RLN TMX 50CTMG/DL
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Meter and test strips were not returned for evaluation, customer declined replacement.Mdr reported based on the "hi" result from the memory, customer was not concerned with meter and will continue to use, customer was educated.Manufacturer contacted customer in a follow-up calls to ensure that the initial concern was resolved.Unable to establish contact with customer at this time.
Event or Problem Description
Consumer reported complaint for error message (e-2).Customer just purchased the meter and test strips on day of call (b)(6) 2021.During the call, a blood test was performed by the customer and produced test result of hi using the meter.The customer was not concerned with the result obtained.The customer feels well and did not report any symptoms.Medical attention is not reported as a result of the actual blood glucose results.The meter memory was not reviewed for previous test result history.
Additional Manufacturer Narrative
Sections with additional information as of 11-mar-2021: h6: updated fda¿s type, findings and conclusions 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: mlc-058: 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.Correction: d1: brand name from "true metrix" to "true metrix air.".

• 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: 11244049
• Report Number: 1000113657-2021-00065
• Device Sequence Number: 4061967
• Product Code: NBW
• UDI-Device Identifier: 00021292012236
• UDI-Public: (01)00021292012236
• 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
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2021

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: 05/31/2022
• Device Model Number: STRIP, RLN TMX 50CTMG/DL
• Device Catalogue Number: REA4H01-01
• Device Lot Number: ZX4164S
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 01/05/2021
• Initial Date Received by Manufacturer: 01/05/2021
• Supplement Date Received by Manufacturer: 02/11/2021
• Initial Report FDA Received Date: 01/28/2021
• Supplement Report FDA Received Date: 03/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1