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

Model Number	METER, PRO MCKESSON TMXMG/DL
Medical Device Problem Codes	Failure to Power Up (1476); Battery Problem (2885)
Health Effect - Clinical Codes	Blurred Vision (2137); Urinary Frequency / Polyuria (2275); Lethargy (2560); Polydipsia (2604)
Date of Event	12/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Meter and test strips were not returned for evaluation.Adverse event report is being submitted due to symptoms related to diabetes ¿ blurry vision, excessive thirst, frequent urination and lethargy.Note: manufacturer contacted customer in several follow-up calls to ensure the patient condition improved and initial concern is resolved - unable to establish contact with customer at this time.
Event or Problem Description
Consumer reported complaint for no responsive-dead meter.Customer is using the professional version, a meter that is intended for facility use.During the call the customer reported symptoms of blurry vision, excessive thirst, frequent urination and lethargy; medical attention was not needed at the time.Customer stated she had obtained the truemetrix pro meter (b)(6) 2020 and the battery had never been changed.The battery is correct for the meter and was in the correct orientation.During the call the truemetrix pro meter did not power on using the power button or when a test strip was inserted.Customer was sent a regular meter as replacement.

• Brand Name: TRUE METRIX PRO
• 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: 11147313
• Report Number: 1000113657-2021-00017
• Device Sequence Number: 3607074
• Product Code: NBW
• UDI-Device Identifier: 10612479210254
• UDI-Public: (01)10612479210254(21)
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K140100
• 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
• Report Date (Section B): 01/11/2021

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: 12/16/2021
• Device Model Number: METER, PRO MCKESSON TMXMG/DL
• Device Catalogue Number: RE4H01P-43
• Device Lot Number: MX4284S
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 12/16/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/16/2020
• Initial Report FDA Received Date: 01/11/2021
• 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