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

Model Number	TRUEMETRIX
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Codes	Neuropathy (1983); Urinary Frequency / Polyuria (2275); Polydipsia (2604)
Date of Event	11/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(manufacturer narrative = t, corrected data = f) (b)(4).Product not yet returned for evaluation.Most likely underlying root cause: mlc-118- user applied blood to strip before inserting strip into meter.Test strip (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.
Event or Problem Description
Consumer reported complaint for e-3 accompanied by symptoms.The expected fasting blood glucose test result range is 100- 200 mg/dl.The customer did report symptoms of fatigue, increase urination, increase thirst, neuropathy.Medical attention is reported as a result of the actual blood glucose results and reported symptoms.The product is stored by customer according to specification in the bedroom.The test strip lot manufacturer's expiration date is 11/30/2018 and open vial date is undisclosed.The meter memory was not reviewed for previous test result history.(customer declined) customer states her normal fasting range is 380 mg/dl-400 mg/dl fasting and physician would like her glucose fasting range to be 100 mg/dl -200 mg/dl fasting.Customer denies the need for medical attention at the time of call and customer states she is having hyperglycemic symptoms of increase urination fatigue and increased thirst and neuropathy advised customer to seek medical attention due to symptoms of hyperglycemia.Customer declined to answer any further questions and due to symptoms call could not be continued.The customer was hospitalized (b)(6) 2017 but declined to answer any further questions.We don't know the reason for the hospitalization.

• 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: 7114211
• Report Number: 1000113657-2017-02064
• Device Sequence Number: 19057582
• Product Code: NBW
• UDI-Device Identifier: 00087701426254
• UDI-Public: (01)00087701426254
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 12/13/2017

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 Model Number: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MU2510
• 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: 11/20/2017
• Initial Report FDA Received Date: 12/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1