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	Battery Problem (2885)
Health Effect - Clinical Code	Dizziness (2194)
Date of Event	06/03/2021
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: lightheaded.Meter and test strips were not returned for evaluation.Products were not replaced.Note: manufacturer contacted customer in several follow-up calls to ensure the customer's condition had improved - unable to establish contact with customer at this time.
Event or Problem Description
Consumer reported complaint for battery issue, stating the true metrix air meter would not turn on.Customer stated the battery had never been changed.During the call, the true metrix air meter powered on using the power button and when a test strip was inserted.During the call, a blood test was performed by the customer non-fasting and produced test result of 188mg/dl using true metrix air meter.The product is stored according to specification in the dining area.The test strip lot manufacturer¿s expiration date is 05/27/2022 and open vial date was not disclosed.At the time of the call, the customer reported feeling lightheaded; medical attention was not needed at the time.

• 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: 12101378
• Report Number: 1000113657-2021-00408
• Device Sequence Number: 19775154
• Product Code: NBW
• UDI-Device Identifier: 00021292007447
• UDI-Public: (01)00021292007447
• 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): 07/01/2021

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: 05/27/2022
• Device Model Number: METER, AIR TVH TMX NFRSMG/DL
• Device Catalogue Number: REA4H01-01
• Device Lot Number: ZX4153S
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 06/03/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/03/2021
• Initial Report FDA Received Date: 07/01/2021
• 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