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 Code	Hyperglycemia (1905)
Date of Event	07/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report # (b)(4).Product not returned for evaluation.Customer declined replacement product at this time.Product is working as designed.Most likely underlying root cause: mlc-18 - user has high glucose value.Test strip (b)(4).Note: manufacturer contacted customer (several attempts) in a follow-up call to ensure that the initial concern was resolved - unable to establish contact with the customer at this time.
Event or Problem Description
Consumer reported complaint for high blood glucose test results.The customer is concerned with test results from results obtained of 303, 292, 441 and 290 mg/dl non-fasting and 292 and 134 mg/dl fasting.The customer's expected fasting blood glucose test result range is 110 - 130 mg/dl; an expected non-fasting range was not provided.At the time of the call, the customer feels well and did not report any symptoms.Customer stated she had been concerned when she had obtained the result of 441 mg/dl non-fasting on (b)(6) 2018 and that she had gone to the emergency room.Customer did not report she had been experiencing any symptoms.At the hospital, the customer's blood glucose test result was 232 mg/dl non-fasting.The diagnosis was hyperglycemia.The customer did not state that she received any treatment.The customer left the hospital the same day.No new medications or healthcare program had been suggested.Customer continued to use the truemetrix meter.During the call on (b)(6) 2018, a back to back blood test was not performed by the customer.The product is stored according to specification; opened vials are stored in the living room and unopened vials in the bedroom closet.The test strip lot manufacturer's expiration date is 08/22/2019 and open vial date is one month.Customer stated that she is sharing the meter with her sister and that the results of 124 and 252 mg/dl are her sister's results; these results were not included in the last five from the meter memory.Customer had disconnected the call; call back attempt had been made and was unable to establish contact with customer.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: 7779090
• Report Number: 1000113657-2018-00858
• Device Sequence Number: 13767678
• Product Code: NBW
• UDI-Device Identifier: 00096295126655
• UDI-Public: (01)00096295126655
• Combination Product (Y/N): N
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 08/13/2018

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: 08/22/2019
• Device Model Number: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MV2796
• 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: 07/19/2018
• Initial Report FDA Received Date: 08/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1