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); Urinary Frequency / Polyuria (2275); Polydipsia (2604)
Date of Event	09/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(manufacturer narrative = t, corrected data = f) (b)(4).Product not returned for evaluation.No replacement product needed at this time.Customer was unable to continue with the call.No address on file for customer.Most likely underlying root cause: mlc-18- user has high glucose value test strip udi# (b)(4).Note: manufacturer contacted customer (several attempts) in a follow-up call in order to ensure the customer's condition since the initial call - unable to establish contact with the customer at this time.Unable to send product notification letter to customer as no address on file.
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.During the call on (b)(6) 2018, a back to back blood test was performed by the customer and produced test results of e-5 and e-5 using truemetrix meter.Customer stated she was using correct testing technique.At the time of the call, the customer stated that she was tired, had dry mouth, increased thirst and increased urination.Customer was going to seek medical intervention due to symptoms.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: 7927051
• Report Number: 1000113657-2018-00988
• Device Sequence Number: 16622826
• Product Code: NBW
• UDI-Device Identifier: 00021292006082
• UDI-Public: (01)00021292006082
• 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): 10/02/2018

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: 10/13/2019
• Device Model Number: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MV2855
• 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: 09/07/2018
• Initial Report FDA Received Date: 10/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1