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	Failure to Power Up (1476)
Health Effect - Clinical Code	Dizziness (2194)
Date of Event	08/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Adverse event report is being submitted due to symptoms related to diabetes: dizziness and contacting doctor.Test strips were not returned for evaluation.Meter was returned.Evaluation in process.Note: manufacturer contacted customer in a follow-up call on 07-sept-2021 to ensure the customer was no longer experiencing symptoms and to ensure the customer¿s initial concern was resolved - able to establish contact with customer.Customer states they are feeling well and replacement products resolved customer¿s initial issue.Unable to confirm if contact with doctor was related to diabetes.
Event or Problem Description
Consumer reported complaint for dead meter.Customer stated the battery had been changed (b)(6) 2021.The customer is using the correct battery in the correct orientation for the meter.During the call, the true metrix air meter did not power on using the power button or when a test strip was inserted.The product is stored according to specification in the bedroom.The test strip lot manufacturer¿s expiration date is 03/25/2022 and open vial date is less than 4 months (exact date was not disclosed).Customer stated that she had tested and obtained a result of 40mg/dl fasting and when she attempted to test again later the true metrix air meter did not power on.At the time of the call the customer reported feeling dizzy and stated she was going to contact her doctor.Customer doctor called while attempted to trouble shoot.Customer did not state why the doctor was calling or if it was related to symptom.Customer disconnected.
Additional Manufacturer Narrative
Sections with additional information as of 11-oct-2021: h3: was the device evaluated by the manufacturer.H6: updated fda¿s type, findings and conclusions codes.H10: test strips were not returned for evaluation.Meter was returned for evaluation.Product testing was performed and no defect found.Most likely underlying root cause: mlc-025: strip inserted backwards or upside-down.

• 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: 12464930
• Report Number: 1000113657-2021-00548
• Device Sequence Number: 1180102
• Product Code: NBW
• UDI-Device Identifier: 00021292007447
• UDI-Public: (01)00021292007447
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2021

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/25/2022
• Device Model Number: METER, AIR TVH TMX NFRSMG/DL
• Device Catalogue Number: REA4H01-01
• Device Lot Number: ZX4055S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2021
• Distributor Facility Aware Date: 08/17/2021
• Initial Date Received by Manufacturer: 08/17/2021
• Supplement Date Received by Manufacturer: 09/14/2021
• Initial Report FDA Received Date: 09/13/2021
• Supplement Report FDA Received Date: 10/11/2021
• 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: Other