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 Codes	Dizziness (2194); Urinary Frequency / Polyuria (2275)
Date of Event	07/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report # (b)(4).Returned meter evaluated with no defect found.Test strips not returned for evaluation.Most likely underlying root cause: mlc-58 - user had an inaccurate reference: self: the person is using themselves as the reference or how they feel at the time they run the blood test.Test strip (b)(4).Note: manufacturer contacted customer (several attempts) in a follow-up call to ensure that the replacement products resolved the initial concern - unable to establish contact with the customer at this time.Product notification letter sent to customer to contact customer care.
Event or Problem Description
Consumer reported complaint for high and erratic blood glucose test results.The customer is concerned with test results from back to back blood tests reported of 145, 131 and 177 mg/dl.The customer's expected fasting blood glucose test result range is 90 - 105 mg/dl.Customer was not using correct testing technique for back to back test.At the time of the call the customer feels well and did not report any symptoms.When customer had obtained the results of concern, she reported she had symptoms of dizziness and frequent urination.Medical attention is not reported as a result of the actual blood glucose results and reported symptoms.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 in the bedroom.Test strip lot manufacturer's expiration date is 07/17/2019 and open vial date is three weeks.The meter memory was reviewed for previous test result history (time / date not set): (b)(6).Customer is getting erratic readings and 2 days ago she had gotten high readings, and was suffering from symptoms of high blood glucose, and had felt ill, was dizzy and had frequent urination.Customer did not need medical assistance.Customer had gotten 145, 131, 177mg/dl when she was not feeling well and those were done fasting back to back.Today she feels fine and is doing well.Customer took battery out twice so the time and date is not correct she does not think she reset it.She also does not take any medication for diabetes.She was not taking the multiple test correctly.She is staying on her same hand but using the same puncture which i told her is not correct but the customer got a little argumentative.

• 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: 7776925
• Report Number: 1000113657-2018-00853
• Device Sequence Number: 16463720
• Product Code: NBW
• UDI-Device Identifier: 00096295126600
• UDI-Public: (01)00096295126600
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 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: 07/17/2019
• Device Model Number: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MV2749
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2018
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2018
• 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