MAUDE Adverse Event Report: TRIVIDIA HEALTH INC TRUE METRIX; SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER

Model Number	STRIP, PRO TMX HSC 50CTMG/DL
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Meter was not returned for evaluation.Test strips were returned for evaluation.Defect was detected.Most likely underlying root cause: rc-061 storage outside specifications.Rc-069 missing chemistry; user washed strips.Note: manufacturer contacted customer in a follow-up call to ensure the customer's products resolved the initial concern - unable to establish contact with customer at this time.No product notification letter sent since no customer address on file.
Event or Problem Description
Consumer reported complaint for low blood glucose test results.(b)(6) is calling on behalf on the customer.The customer is concerned with the test results from results obtained in the 40's and 50's.The expected fasting blood glucose test result is undisclosed.The customer did not report symptoms.Medical attention is not reported as a result of the actual blood glucose results.The product storage location is undisclosed.During the call a back to back test was not performed.The test strip lot manufacture's expiration date is 01/30/2021 and the open vial date is undisclosed.The meter memory was not reviewed for previous test result history.

• Brand Name: TRUE METRIX
• Common Device Name: SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER
• Manufacturer (Section D): TRIVIDIA HEALTH INC; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 9412177
• Report Number: 1000113657-2019-10205
• Device Sequence Number: 14503625
• Product Code: NBW
• UDI-Device Identifier: 00021292007867
• UDI-Public: (01)00021292007867
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K140100
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 12/04/2019

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: Health Professional
• Device Expiration Date: 01/30/2021
• Device Model Number: STRIP, PRO TMX HSC 50CTMG/DL
• Device Catalogue Number: RE4H01P-43
• Device Lot Number: MW3442S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2019
• Distributor Facility Aware Date: 10/17/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/20/2019
• Initial Report FDA Received Date: 12/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1