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	Urinary Frequency / Polyuria (2275); Polydipsia (2604)
Date of Event	11/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not returned for evaluation.Customer declined replacement product at this time.Customer will not use our product anymore.Most likely underlying root cause: mlc-18- user has high glucose value test strip udi# (b)(4).Manufacturer contacted customer on (b)(6) 2018 in a follow-up call to ensure the customer's condition since the initial call; customer's condition had improved and he did not currently have any diabetic symptoms.Customer stated that he had pneumonia three months ago and started nebulizer treatment and so symptoms he was having may not be related to his diabetes.Customer stated he had gone to the hospital that day.Customer's blood glucose test result when at the hospital was 90 mg/dl fasting (glucose meter).Customer stated there was no diagnosis and he did not receive any treatment.No new medications or healthcare program was suggested.Customer was discharged the same day.Customer will discontinue using the truemetrix meter and declined replacement products.
Event or Problem Description
Consumer reported complaint for e-5 error: test strip error.The e-5 error occurred when the blood sample was absorbed.At the time of the call, the customer reported feeling ill with symptoms of dry mouth, increased thirst and increased urination.Customer was going to go to the doctor.Customer was unable to continue with the troubleshooting process and no further information was able to be obtained.

• 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: 8106966
• Report Number: 1000113657-2018-01203
• Device Sequence Number: 11269218
• Product Code: NBW
• UDI-Device Identifier: 00052569138557
• UDI-Public: (01)00052569138557
• 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): 11/27/2018

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: 03/25/2020
• Device Model Number: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MV2939
• 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: 11/02/2018
• Initial Report FDA Received Date: 11/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1