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

Model Number KIT, AIR HUMANA TMX STR MG/DL

Device Problems High Test Results (2457); Output Problem (3005)

Patient Problem No Information (3190)

Event Date 01/27/2021

Event Type  Injury  

Manufacturer Narrative

Internal report reference number: (b)(4).Meter and test strips were not returned for evaluation.Note: manufacturer contacted customer multiple follow-up calls to ensure that the initial concern was resolved and to find out customer's condition - unable to establish contact with customer at this time.

Event Description

Consumer reported complaint for dead meter and high blood glucose test results.The customer is concerned with pm tests results of 186mg/dl obtained.The expected am fasting blood glucose test result range is 99-105mg/dl.Customer stated that he ate cereal this morning at 8am and testing 3 hours later and blood sugar was high.The customer did report symptom at time of call but did not wish to disclose.Medical attention is not reported as a result.Customer attempted to run blood test and meter is a dead meter and stated that battery was changed two months ago.The meter does not power on with strips.Meter does not power on with button.The product is stored according to specification in the bedroom.During the call a back to back blood test was not performed by the customer.The test strip lot manufacturer¿s expiration date is 06/30/2022 and open vial date is 1/24/2021.The meter memory was reviewed for previous test result history.(b)(6).

Manufacturer Narrative

Sections with additional information as of 11-may-2021: h6: updated fda¿s type, findings and conclusions codes.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 strip lot tested within specifications.Most likely underlying root cause: mlc-058: user had an inaccurate reference: self: the person is using themselves as the reference or how they feel at the time they run the blood test.

• Brand Name: TRUE METRIX AIR
• Type of Device: SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER
• Manufacturer (Section D): TRIVIDIA HEALTH INC; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 11344982
• MDR Text Key: 232517322
• Report Number: 1000113657-2021-00126
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00021292007720
• UDI-Public: (01)00021292007720(
• Combination Product (y/n): N
• PMA/PMN Number: K150052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 05/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2022
• Device Model Number: KIT, AIR HUMANA TMX STR MG/DL
• Device Catalogue Number: REA4H01-01
• Device Lot Number: ZX4212S
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 01/27/2021
• Date Manufacturer Received: 04/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other