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

Model Number METER, TRUE METRIX NFRSMG/DL

Device Problem High Test Results (2457)

Patient Problems Hyperglycemia (1905); High Blood Pressure/ Hypertension (1908); Dizziness (2194)

Event Date 05/17/2021

Event Type  Injury  

Manufacturer Narrative

Internal report reference number: (b)(4).Meter was not returned for evaluation.Test strips were returned for evaluation.Product testing was performed and defect found on returned strips: no response.Returned test strips were forwarded to r&d for additional investigation.R&d investigation observed scratches along the electrode in the conductive ptf area of the returned test strips.Root cause: rc-071: excessive insertion and removal of strip from meter.Note 1: manufacturer contacted customer in a follow-up call on 19-may-2021 to ensure the customer's condition had improved - able to establish contact with customer who stated her condition had improved and she was not currently experiencing any diabetic symptoms.Customer stated the dizziness was due to high blood pressure.No medical intervention since the last call was reported.Note 2: manufacturer contacted customer in a follow-up call on 27-may-2021 to ensure the replacement products resolved the initial concern - able to establish contact with customer who stated replacement products resolved initial concern.Customer also stated she had performed a blood test that morning using her original true metrix meter, had obtained a blood glucose test result of 98 mg/dl fasting and was satisfied with the result obtained.

Event Description

Consumer reported complaint for high blood glucose test results; customer also stated the true metrix meter did not turn on upon test strip insertion.Customer stated the battery had been changed a few days prior to the call; customer is using the correct battery with the correct orientation.During the call the true metrix meter powered on by using the power button, but not when a test strip was inserted.At the time of the call, the customer reported feeling dizzy; medical attention was not needed at the time.Customer stated that on (b)(6) 2021 she had obtained a high blood glucose test result of 240 mg/dl using the true metrix meter; customer did not recall if result was fasting or non-fasting.The customer's expected glucose test result range was not provided.Customer stated her blood pressure had also been high.Customer's granddaughter had taken her to the er; customer's blood glucose test result at the er was 343 mg/dl fasting.Customer was diagnosed with hyperglycemia and hypertension, and was treated with iv metformin and glimepiride.Customer stated they had also monitored her heart and a cat scan had been performed.Customer had been discharged the same day.Customer had been advised to drink plenty of water and to test her blood glucose three times a day.The dosage of her metformin and glimepiride had also been increased and a follow up appointment with her doctor scheduled for (b)(6) 2021.

• 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: 11992231
• MDR Text Key: 255971777
• Report Number: 1000113657-2021-00376
• 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: Replace
• Type of Report: Initial
• Report Date: 06/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/20/2022
• Device Model Number: METER, TRUE METRIX NFRSMG/DL
• Device Catalogue Number: RE4H01-81
• Device Lot Number: ZX4241S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2021
• Distributor Facility Aware Date: 05/18/2021
• Date Manufacturer Received: 05/18/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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