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

Model Number KIT, RLN AIR TMX METER

Device Problem Failure to Power Up (1476)

Patient Problems Diaphoresis (2452); Confusion/ Disorientation (2553); Increased Appetite (4570)

Event Date 11/01/2021

Event Type  Injury  

Event Description

Consumer reported complaint the true metrix air meter did not power on when a test strip was inserted.Girlfriend is calling on behalf of the customer.The customer is not using the correct test strips for the meter; customer was using relion premier test strips with the true metrix air meter.Girlfriend stated that the night before, (b)(6) 2021, customer had missed an insulin shot; customer had then administered his last dose of insulin between 11:30 pm-12:00 am.The following morning, (b)(6) 2021, customer had not been feeling well, with symptoms of cold sweats, extreme hunger and confusion.Customer was not able to perform a blood glucose test due to the meter not powering on when the incorrect test strip was inserted.Girlfriend had taken customer to the hospital where he was admitted.Customer's blood glucose test result when at the hospital had been 60 mg/dl fasting and he had been given candy.A second blood test was performed and customer's blood glucose test result had been 80 mg/dl non-fasting; girlfriend did not recall the time between the two tests but had stated it was probably within an hour.The customer's diagnosis is unknown as the customer was currently still in the hospital at the time of the call.The customer was sleeping at the time of the call; girlfriend was unable to confirm how the customer was feeling at the time.

Manufacturer Narrative

Internal report reference number: (b)(4).Meter and test strips were not returned for evaluation.Note: manufacturer contacted customer in several follow-up calls to ensure the customer's condition had improved and that the replacement products resolved 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: 12868067
• MDR Text Key: 281195902
• Report Number: 1000113657-2021-00745
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00021292007720
• UDI-Public: (01)00021292007720
• 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: Other,Consumer
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 11/24/2021

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: KIT, RLN AIR TMX METER
• Device Catalogue Number: REA4H01-01
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 11/01/2021
• Initial Date Manufacturer Received: 11/01/2021
• Initial Date FDA Received: 11/24/2021
• 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