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

Model Number STRIP, TMX GNP 30CT24/CASE MG/DL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Low Blood Pressure/ Hypotension (1914); Dizziness (2194); Shaking/Tremors (2515)

Event Date 11/30/2022

Event Type  Injury  

Event Description

Consumer called for training on how to use truedraw lancing device - internal report reference (b)(4).During the call, a blood test was performed by the customer non-fasting and produced test result of 131 mg/dl; customer was unsure if this was a good result for her.At the time of the call the customer reported symptoms of dizziness and feeling shaky.Customer stated due to the symptoms she had called the hospital that morning; customer let them know she was not diabetic and they had recommended she test her blood glucose.The customer's test strips are expired: manufacturer¿s expiration date is 09/30/2021.Product storage and open vial date were not disclosed.

Manufacturer Narrative

Internal report reference number: (b)(4).Additional report reference number (b)(4) (lancing device).Meter and test strips were not returned for evaluation.Most likely underlying root cause: mlc-012: product expired.Manufacturer contacted customer in a follow-up call on 01-dec-2022 to ensure that the customer's condition had improved - able to establish contact with customer who stated her condition has not improved and that she is still feeling shaky.Customer stated she was going to see her doctor to find out what is causing her symptoms.Note 2: manufacturer contacted customer in a follow-up call on 02-dec-2022 to ensure that the customer's condition had improved - able to establish contact with customer who stated her condition had improved and she did not currently have any diabetic symptoms.Customer stated she had gone to the hospital the day prior and her blood pressure had been low; they did not test her blood sugar.Customer was given medication for her blood pressure and was discharged the same day.After discharge, customer stated her cardiologist had informed her it was probably the medication for her blood pressure that caused the symptoms and that she should take medications with food.Customer stated that is not sure it is really the blood pressure and sated that she needs to check her blood sugar to make sure.Manufacturer contacted customer in a follow-up call on 06-dec-2022 to ensure the replacement products resolved the initial concern - able to establish contact with customer who stated replacement products resolved initial concern.

• 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: 16051241
• MDR Text Key: 306172084
• Report Number: 1000113657-2022-00671
• Device Sequence Number: 1
• Product Code: NBW
• 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: 12/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2021
• Device Model Number: STRIP, TMX GNP 30CT24/CASE MG/DL
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MX4318S
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 11/30/2022
• Date Manufacturer 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; Other