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

Model Number METER, TRUE METRIX AIRBLANK MG/DL

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/22/2022

Event Type  malfunction  

Event Description

Consumer reported complaint for the true manager air app displaying false lo.Customer stated they had upgraded the software on their iphone to ios 16, and when the phone is synced with the app, the new blood glucose test results display as lo.No symptoms and no medical attention associated with the use of the product was reported.Customer reported complaint via e-mail, no further information was provided.

Manufacturer Narrative

(b)(4).Meter was not returned for evaluation.Note: manufacturer contacted customer in several follow-up e-mails to obtain additional information and to provide support with the initial concern - unable to establish contact with customer at this time.

• 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
• Manufacturer Contact: karen devincent ; 2400 nw 55th court; fort lauderdale, FL 33309
• MDR Report Key: 15614396
• MDR Text Key: 304200441
• Report Number: 1000113657-2022-00550
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150052
• 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: 10/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: METER, TRUE METRIX AIRBLANK MG/DL
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 09/22/2022
• Date Manufacturer Received: 09/22/2022
• 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