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

Model Number	METER, ARRIVA TMXMETER ONLY MG/DL
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Meter was returned for evaluation.No defect was detected.Test strips were not returned for evaluation.Most likely underlying root cause: mlc-55: user had an inaccurate reference: competitor¿s meter: the end user is comparing results obtained from trividia¿s bgm system to the results from a competitor¿s bgm system.Note: manufacturer contacted customer in a follow-up call to ensure the replacement products resolved the initial concern - able to establish contact with customer and stated has not yet used the meter.Meter was set up with customer on call.
Event or Problem Description
Consumer reported complaint for low blood glucose test results.Husband is calling on behalf of the customer.The customer is concerned with tests results from results obtained of 54 and 66mg/dl.The expected fasting blood glucose test result range is 90-110mg/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 according to specification in the bedroom and or living room.During the call a blood test was performed by the customer and produced test results of 96mg/dl fasting using meter.The test strip lot manufacturer¿s expiration date is 10/31/2020 and open vial date is undisclosed.(b)(6).

• 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: 9278849
• Report Number: 1000113657-2019-10125
• Device Sequence Number: 11308048
• Product Code: NBW
• UDI-Device Identifier: 00021292007041
• UDI-Public: (01)00021292007041
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 11/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/31/2020
• Device Model Number: METER, ARRIVA TMXMETER ONLY MG/DL
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MW3301S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2019
• Distributor Facility Aware Date: 10/14/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/14/2019
• Initial Report FDA Received Date: 11/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1