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

Model Number	KIT, TMX NFRS STARTERMG/DL
Medical Device Problem Code	Image Display Error/Artifact (1304)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Products were not returned for evaluation.Note: manufacturer contacted customer in several follow-up calls to ensure the initial concern is resolved - unable to establish contact with customer at this time.
Event or Problem Description
Consumer reported complaint for defective lcd display, stating the truemetrix meter displayed partial numbers.Customer stated he obtained a result of "137 mg/dl fasting" but was unsure if it was "187 mg/dl" and that he had administered 30 units of insulin.The customer feels well and did not report any symptoms.No medical attention associated with the use of the product was reported.During the call, the customer turned the truemetrix meter on and stated that when the screen came on, the 888's were showing partial numbers.Customer's test strips are expired; manufacturer¿s expiration date is 02/21/2020.Customer advised that the truemetrix meter has never been dropped or mishandled.

• 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: 11265838
• Report Number: 1000113657-2021-00071
• Device Sequence Number: 1219084
• Product Code: NBW
• UDI-Device Identifier: 00021292006075
• UDI-Public: (01)00021292006075
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 02/02/2021

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: 02/21/2020
• Device Model Number: KIT, TMX NFRS STARTERMG/DL
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MV2896
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 01/06/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/06/2021
• Initial Report FDA Received Date: 02/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1