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

Model Number KIT, LEADER TMX METERMG/DL

Device Problem Battery Problem (2885)

Patient Problem Hypoglycemia (1912)

Event Date 10/26/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Adverse event report is being submitted due to seeking medical attention meter and test strips were not returned for evaluation.Products were not replaced.Note: manufacturer contacted customer in a follow-up call on 15-nov-2021 to ensure the customer¿s initial concern was resolved - able to establish contact with customer.Customer stated initial concern has been resolved and is comfortable with the glucose readings from the products.

Event Description

Consumer reported complaint for the true metrix meter was not powering on when a test strip was inserted.Customer stated she has had the true metrix meter for three months and the battery has never been changed.The customer is using the correct battery, in the correct orientation for the meter.The test strip lot manufacturer's expiration date is 11/19/2022 and open vial date was not disclosed.During the call the true metrix meter powered on using the power button and when a test strip was inserted.During the call, a blood test was performed by the customer non-fasting and produced test result of 79 mg/dl using true metrix meter; customer was satisfied with the result obtained.The customer feels well and did not report any symptoms.Customer stated she had gone to the hospital two weeks ago.Customer stated she was not able to get the true metrix meter to work.Customer felt symptoms and went to hospital.Customer stated her blood glucose was low in the 40's when she went to the hospital.Customer was diagnosed/treated for hypoglycemia and was advised to follow-up with her doctor.

• 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: 12857874
• MDR Text Key: 285622814
• Report Number: 1000113657-2021-00731
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00021292007928
• UDI-Public: (01)00021292007928
• 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: 11/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/19/2022
• Device Model Number: KIT, LEADER TMX METERMG/DL
• Device Catalogue Number: RE4H01-81
• Device Lot Number: ZY4354S
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 10/26/2021
• Date Manufacturer Received: 10/26/2021
• 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