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

Model Number	STRIP, RLN TMX 100CTMG/DL
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Codes	Blurred Vision (2137); Dizziness (2194)
Date of Event	06/12/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Meter and test strips were not returned for evaluation.Most likely underlying root cause: mlc-62: user had poor technique.Adverse event report is being submitted due to symptoms related to diabetes - blurred vision and dizziness.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.
Event or Problem Description
Consumer reported complaint for e-0 error.At the time of the call the customer reported feeling dizzy and having blurry vision.Customer stated she was going to seek medical intervention and could not continue with the call.No further information was able to be obtained.(b)(6).
Additional Manufacturer Narrative
Sections with additional information as of 26-aug-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.

• 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: 10250419
• Report Number: 1000113657-2020-00471
• Device Sequence Number: 514801
• 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): 08/27/2020

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: 12/13/2020
• Device Model Number: STRIP, RLN TMX 100CTMG/DL
• Device Catalogue Number: REA4H01-01
• Device Lot Number: MW3360S
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 06/12/2020
• Initial Date Received by Manufacturer: 06/12/2020
• Supplement Date Received by Manufacturer: 07/28/2020
• Initial Report FDA Received Date: 07/09/2020
• Supplement Report FDA Received Date: 08/27/2020
• 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