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

Model Number STRIP, TRUE METRIX 50CTMG/DL

Device Problem Image Display Error/Artifact (1304)

Patient Problems Blurred Vision (2137); Urinary Frequency (2275); Polydipsia (2604)

Event Date 12/02/2022

Event Type  Injury  

Manufacturer Narrative

Internal report reference number: (b)(4).Meter and test strips were not returned for evaluation.Most likely underlying root cause: mlc-018: user has high glucose value.Note: manufacturer contacted customer in a follow-up call on (b)(6) 2022 to ensure the customer's condition had improved and that the initial concern is resolved - able to establish contact with customer who stated her condition had improved and she did not currently have any diabetic symptoms.Customer reported medical intervention since the last call, stating that the week prior she had been hospitalized for a few days.Customer's blood glucose test result when at the hospital had been over 400 mg/dl (fasting/non-fasting not disclosed).Customer had been treated with metformin.Customer had been discharged and advised to follow-up with her primary care physician.Customer could not recall the exact dates of the hospitalization.Customer stated she had been provided with a new true metrix meter.

Event Description

Consumer reported complaint for error message (e-5).At the time of the call the customer reported symptoms of blurry vision, excessive thirst and frequent urination.Medical attention was not needed at the time of the call.The customer did not have the products with her at the time of the call and was unable to provide the meter serial number and test strip lot number.Customer stated she would call manufacturer back.No further information was able to be obtained.

• 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: 16005876
• MDR Text Key: 305725354
• Report Number: 1000113657-2022-00664
• 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: Other
• Type of Report: Initial
• Report Date: 12/19/2022

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 Model Number: STRIP, TRUE METRIX 50CTMG/DL
• Device Catalogue Number: RE4H01-81
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 12/02/2022
• Initial Date Manufacturer Received: 12/02/2022
• Initial Date FDA Received: 12/19/2022
• 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