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

Model Number	KIT, RLN AIR TMX METERMG/DL
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	Diaphoresis (2452)
Date of Event	05/18/2021
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: diaphoresis (sweating).Meter and test strips were not returned for evaluation- customer declined replacement.Note: manufacturer contacted customer in several follow-up calls to ensure the customer's condition had improved and that the initial concern is resolved - unable to establish contact with customer at this time.
Event or Problem Description
Consumer reported complaint for dead meter, stating that the true metrix air meter would not power on.At the time of the call, the customer reported that she was sweating; medical attention was not needed at the time.Customer stated that the battery had been changed on (b)(6) 2021; customer is using the correct battery for the meter.The battery orientation had not been correct- the battery had been turned incorrectly in the meter.During the call, the meter powered on using the power button and when a test strip was inserted.A blood test was performed by the customer non-fasting and produced test result of 169 mg/dl using true metrix air meter; customer was satisfied with the result obtained.

• 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: 11990732
• Report Number: 1000113657-2021-00374
• Device Sequence Number: 10974722
• Product Code: NBW
• UDI-Device Identifier: 00021292012236
• UDI-Public: (01)00021292012236
• 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): 06/14/2021

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: 06/22/2022
• Device Model Number: KIT, RLN AIR TMX METERMG/DL
• Device Catalogue Number: REA4H01-01
• Device Lot Number: ZX4191S
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/18/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/18/2021
• Initial Report FDA Received Date: 06/14/2021
• 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