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

Model Number STRIP, TMX HNO 50CT24/CS MG/DL

Device Problem High Test Results (2457)

Patient Problems Muscle Weakness (1967); Urinary Frequency (2275); Polydipsia (2604)

Event Date 10/11/2022

Event Type  Injury  

Manufacturer Narrative

Internal report reference number: (b)(4).Meter and test strips were not returned for evaluation.Added most likely underlying root cause onto case as the complaint product was not returned for investigation.Most likely underlying root cause: mlc-018 - user has high glucose value manufacturer contacted customer in a follow-up call on 12-oct-2022 to ensure that the customer's condition had improved - able to establish contact with customer who stated he was not currently having any diabetic symptoms.Customer stated he spoke with his doctor and that he has an infection in his tooth and he was advised that is why his blood sugars are elevated.Customer stated that he did go to the dentist that morning for x-rays.Manufacturer contacted customer in a follow-up call on 28-oct-2022 to ensure that the customer's condition had improved and that the initial concern was resolved - able to establish contact with customer who stated his condition had improved and he did not currently have any diabetic symptoms.Customer reported recent hospitalization due to feeling weak (unable to recall exact date).Customer's blood glucose test result when at the hospital had been over 500 mg/dl (fasting/non-fasting undisclosed) and customer was treated with insulin to bring his blood sugar to 215 mg/dl fasting am and a strict diet.Customer stated he was not provided a diagnosis but they had told him he was very close to ketoacidosis.Customer stated they had increased his dosage of metformin to 2000 mg, prescribed him glipizide and took him off jardiance.Customer stated he had been hospitalized for three days.Customer stated that after he was discharged from the hospital, he saw his pcp for a follow up appointment and she changed his dosage of metformin from 2000 mg to 1500 mg and advised him to test his blood sugar twice a day every other day am fasting and bedtime.Customer stated he had received a replacement meter from his doctor and that he is comfortable with the results; customer stated he discarded his meter/test strips.

Event Description

Consumer reported complaint for high blood glucose test results.The customer is concerned with test results from results obtained of 490 mg/dl.The customer does not know their expected blood glucose test result range.At the time of the call the customer reported symptoms of frequent urination and increased thirst.Customer also mentioned he is sick with a sore throat, possible allergies, as per his doctor and started taking claritin.Customer advised that he has a call into his doctor to find out what he needs to do.During the call, a blood test was performed by the customer fasting and produced test results of 574 mg/dl using true metrix meter.The product is stored according to specification.The test strip lot manufacturer¿s expiration date is 08/31/2023 and open vial date is 10/11/2022.The meter memory was not reviewed for previous test result history.

Manufacturer Narrative

Sections with additional information as of 30-nov-2022: h6: updated fda's type of investigation, investigation findings, and investigation conclusions.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 strips tested within specifications.Most likely underlying root cause: mlc-018: user has high glucose value.

• Brand Name: TRUE METRIX
• Type of Device: SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER
• Manufacturer (Section D): TRIVIDIA HEALTH INC; 2400 nw 55th court; fort lauderdale FL 33309
• Manufacturer Contact: karen devincent ; 2400 nw 55th court; fort lauderdale, FL 33309
• MDR Report Key: 15734781
• MDR Text Key: 303076245
• Report Number: 1000113657-2022-00583
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00021292007836
• UDI-Public: (01)00021292007836
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140100
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/30/2022

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2023
• Device Model Number: STRIP, TMX HNO 50CT24/CS MG/DL
• Device Catalogue Number: RE4H01-81
• Device Lot Number: ZY4684S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 10/11/2022
• Initial Date Manufacturer Received: 10/11/2022
• Initial Date FDA Received: 11/04/2022
• Supplement Dates Manufacturer Received: 11/07/2022
• Supplement Dates FDA Received: 11/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization