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

Model Number	TRUEMETRIX
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Codes	Headache (1880); Polydipsia (2604)
Date of Event	04/23/2018
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-58-user had an inaccurate reference: self: the person is using themselves as the reference or how they feel at the time they run the blood test.Test strip (b)(4).Note: manufacturer contacted customer on 4/24/2018 in a follow-up call in order to ensure the customer's condition since the initial call; customer's condition had not improved and she stated she had a headache and frequent thirst.Customer did not have any medical intervention since the last call.Customer stated she was going to call her doctor.After several attempts manufacturer contacted customer on 5/1/2018 in a follow-up call in order to ensure the customer's condition since the initial call; customer condition improved.No symptoms or medical attention reported since the original call.Customer satisfied with the replacement product.
Event or Problem Description
Consumer reported complaint for high blood glucose test results.The customer is concerned with tests results from non-fasting result obtained of 195 mg/dl.The customer's expected non-fasting blood glucose test result range is 95 - 131 mg/dl; expected fasting blood glucose test result range is 70 - 90 mg/dl.Customer was not concerned with erratic results.At the time of the call, the customer reported symptom of excessive thirst.Customer stated she had felt that way for some time and that she has been in communication with her doctor about it.Medical attention was not needed at the time of the call.During the call on (b)(6) 2018, a back to back blood test was performed by the customer fasting and produced test results of 198 mg/dl and 114 mg/dl using truemetrix meter.The product is stored according to specification in a walk in closet.The test strip lot manufacturer's expiration date is 05/31/2019 and open vial date is (b)(6) 2018.Customer had two vials of the same lot number of test strips and customer stated she had obtained high results with both vials.The meter memory was reviewed for previous test result history: (b)(6).

• 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: 7521983
• Report Number: 1000113657-2018-00558
• Device Sequence Number: 1176264
• Product Code: NBW
• UDI-Device Identifier: 00050428275283
• UDI-Public: (01)00050428275283
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 05/17/2018

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: 05/31/2019
• Device Model Number: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MU2700
• 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: 04/23/2018
• Initial Report FDA Received Date: 05/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1