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

Model Number	METER, AIR TVH TMX NFRSMG/DL
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	01/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Meter and test strips were not returned for evaluation.
Event or Problem Description
Customer called for training on performing a blood test.Both vials of test strips the customer had available were expired: mt2142, manufacturer's expiration date of 04/24/2018 and mt1782, manufacturer's expiration date of 10/28/2017.Customer stated she had the meter for several years and that when she first got it she didn't like it, so she had stored it and didn't use it.Customer was going to purchase new test strips.At the time of the call, the customer felt well and did not report any symptoms.During the call, the customer had stated that earlier that morning she had been "out of it", screaming and carrying on.Customer's son's had called 911.When the paramedics arrived they had performed a blood test using their device and had obtained a result of 15 mg/dl (not disclosed if fasting or non-fasting).Customer had been treated with an injection of dextrose and told to eat.Prior to leaving, the paramedics had tested customer's blood glucose and the result had been 156 mg/dl non-fasting.Customer had declined to go to the hospital.

• Brand Name: TRUE METRIX AIR
• Common Device Name: SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER
• Manufacturer (Section D): TRIVIDIA HEALTH INC; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 11277042
• Report Number: 1000113657-2021-00077
• Device Sequence Number: 2590581
• Product Code: NBW
• UDI-Device Identifier: 00021292007447
• UDI-Public: (01)00021292007447(21)
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K150052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 02/03/2021

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/24/2018
• Device Model Number: METER, AIR TVH TMX NFRSMG/DL
• Device Catalogue Number: REA4H01-01
• Device Lot Number: MT2142
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 01/08/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/08/2021
• Initial Report FDA Received Date: 02/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention