MAUDE Adverse Event Report: TRIVIDIA HEALTH, INC. TRUEMETRIX; BLOOD GLUCOSE SYSTEM

Model Number	TRUEMETRIX
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Codes	Fatigue (1849); Dizziness (2194)
Date of Event	12/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not returned for evaluation.No replacement product needed at this time.Most likely underlying root cause: mlc-22 - client is testing with expired test strips test strip udi# (b)(4).Note: manufacturer contacted customer on (b)(6) 2018, in a follow-up call in order to ensure the customer's condition since the initial call - customer's condition had improved, and she did not currently have any diabetic symptoms.Medical intervention since the last call was reported.Due to not feeling well, customer had gone to her doctor's office.Customer stated at the doctor's office they had drawn blood and she had drank one liter of water.Customer's blood glucose test result when at the doctor's office was 220 mg/dl non-fasting.No new medications or healthcare program had been suggested.Customer had tested using the truemetrix meter and had obtained a result of 140 mg/dl fasting.
Event or Problem Description
Customer reported complaint stating she sees err.At the time of the call, the customer reported feeling tired and dizzy.Customer was instructed to seek medical intervention.Customer's test strips are expired - manufacturer's expiration date is 01/26/2018.

• Brand Name: TRUEMETRIX
• Common Device Name: BLOOD GLUCOSE SYSTEM
• Manufacturer (Section D): TRIVIDIA HEALTH, INC.; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 8257946
• Report Number: 1000113657-2019-00040
• Device Sequence Number: 1921189
• Product Code: NBW
• UDI-Device Identifier: 00021292006051
• UDI-Public: (01)00021292006051
• Combination Product (Y/N): N
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 01/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/26/2018
• Device Model Number: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MT1898
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2018
• Initial Report FDA Received Date: 01/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1