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	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	09/22/2020
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-62: user had poor technique.Note: manufacturer contacted customer in a follow-up call on 30-sep-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 e-3 error.Customer stated that he has had the truemetrix meter for several years.Customer was using the proper testing technique.During the call, a blood test was performed by the customer fasting and produced test result of 130 mg/dl using truemetrix meter.Customer was satisfied with the result obtained.At the time of the call the customer felt well and did not report any symptoms.Customer stated that he had been hospitalized two months ago due to hyperglycemia and low blood pressure.Customer did not disclose why he had sought medical intervention.Customer stated that his blood glucose test result when admitted to the hospital had been 731 mg/dl.Customer was treated with insulin and was diagnosed with diabetes.Customer stated he remained in the hospital for 2-2 1/2 days.Upon discharge customer was prescribed insulin and heart medications.Prior to being hospitalized, customer stated that he had been pre-diabetic and had been taking oral medication.
Additional Manufacturer Narrative
Sections with additional information as of 21-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.

• 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: 10693263
• Report Number: 1000113657-2020-00763
• Device Sequence Number: 571262
• Product Code: NBW
• UDI-Device Identifier: 00021292006075
• UDI-Public: (01)00021292006075
• Combination Product (Y/N): N
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2020

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: 01/16/2022
• Device Model Number: KIT, TMX NFRS STARTERMG/DL
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MX4327S
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 09/22/2020
• Initial Date Received by Manufacturer: 09/22/2020
• Supplement Date Received by Manufacturer: 11/24/2020
• Initial Report FDA Received Date: 10/16/2020
• Supplement Report FDA Received Date: 12/21/2020
• 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: Required Intervention