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

Model Number	TRUEMETRIX
Medical Device Problem Code	Incorrect Or Inadequate Test Results (2456)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/24/2017
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-62- user had poor technique.Test strip (b)(4).
Event or Problem Description
Consumer reported complaint for erratic blood glucose results.The customer is concerned with the result of 291 mg/dl.The expected fasting blood glucose test result range is 120 to 130 mg/dl.The customer did not report symptoms.Medical attention is not reported as a result of the actual blood glucose results.The product is stored by customer according to specification.During the call on (b)(6) 2017, a back to back blood test was performed non-fasting by the customer and produced test results of 222 and 206 mg/dl using true metrix air meter.The test strip lot manufacturer's expiration date is 11/15/2018 and open vial date is within the month of (b)(6) 2017.The meter memory was reviewed for previous test result history.(date/time not stored correctly) (b)(6).Customer called in stating the meter is reading erratic.Customer states that she was concerned when she obtained a result of 291 mg/dl she was concerned that the results were high, customer tested again on a different finger and the results was 160 mg/dl.Customer is now concerned that the meter is erratic.Customer is more concerned that the meter is reading erratic than high.Non-fasting range is 150-160 mg/dl.

• 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: 6875420
• Report Number: 1000113657-2017-01712
• Device Sequence Number: 1444192
• Product Code: NBW
• UDI-Device Identifier: 00021292007010
• UDI-Public: (01)00021292007010
• Combination Product (Y/N): N
• Initial Reporter State: FL
• PMA/510(K) Number: K150052
• 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): 09/19/2017

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: REA4H01-01
• Device Lot Number: MU2470
• 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: 08/24/2017
• Initial Report FDA Received Date: 09/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1