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	Blurred Vision (2137); Urinary Frequency / Polyuria (2275); Polydipsia (2604)
Date of Event	10/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not yet returned for evaluation.Most likely underlying root cause: mlc-14- insufficient blood sample applied to strip (user) test strip udi#((b)(4).Note: manufacturer contacted customer on 11/9/2018 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 e-2 error: sample not detected or using wrong test strip.Wife is calling on behalf of the customer.The e-2 error occurred when the blood sample was absorbed.Customer was using the correct test strips for the meter.During the call, back to back blood tests were performed by the customer and produced test results of e-2 and e-2 using truemetrix meter.At the time of the call, customer's wife reported customer was frequently thirsty, had blurry vision, frequent urination, felt weak and was hungry.Customer was advised to seek medical attention.Customer was unable to continue with the troubleshooting process and no further information was able to be obtained.At call back on (b)(6) 2018, the customer's condition had improved and he did not currently have any diabetic symptoms.Customer stated that on (b)(6) 2018 he had gone to the eye doctor and that his vision is no longer blurry.The customer's blood glucose test result when at the doctor's office was 190 mg/dl and the doctor told customer to take his insulin.The customer was also able to continue with the troubleshooting process.The product is stored according to specification in the bedroom.The test strip lot manufacturer's expiration date is 02/15/2020 and open vial date is (b)(6) 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: 8094952
• Report Number: 1000113657-2018-01194
• Device Sequence Number: 16842035
• Product Code: NBW
• UDI-Device Identifier: 00010939719447
• UDI-Public: (01)00010939719447
• Combination Product (Y/N): N
• Initial Reporter State: TX
• PMA/510(K) Number: K140100
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 11/21/2018

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: 02/15/2020
• Device Model Number: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MV2897
• 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: 10/31/2018
• Initial Report FDA Received Date: 11/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1