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	Fatigue (1849); Blurred Vision (2137); No Code Available (3191)
Date of Event	04/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not returned for evaluation.Customer declined replacement product at this time.Most likely underlying root cause of malfunction: user has high glucose value (b)(4).Note: during the follow-up call on (b)(6) 2017, the customer stated that her condition had improved and she was not currently having any diabetic symptoms.The customer stated that she had gone to the hospital on (b)(6) 2017.The customer stated the hospital diagnosis had been hyperglycemia.Customer stated she had received insulin iv which had brought her blood glucose from 600 mg/dl to 372 mg/dl and then she had been released (date not disclosed).The customer stated she felt much better; customer did want to give any further details and disconnected the call.
Event or Problem Description
Consumer reported complaint for high blood glucose test results.Daughter is calling on behalf of the customer.The customer is concerned with test results from results obtained of 497 mg/dl.The customer's expected fasting blood glucose test result range is 125 - 155 mg/dl.Customer did not have hga1c information.During the call on (b)(6) 2017, the customer reported symptoms of blurry vision, thirsty and tired.Customer stated the day prior to call she had obtained a result of 600 mg/dl and had called her doctor; the doctor had not returned her phone call.Customer called her doctor during the phone call on (b)(6) 2017; the doctor's nurse told customer that she would have doctor call her back.During the call on (b)(6) 2017, a back to back blood test was not performed by the customer.The product is stored according to specification.The test strip lot manufacturer's expiration date is 04/25/2018 and open vial date is (b)(6) 2017.Customer did not want to go through the meter memory to obtain other results, so blood glucose of 497 mg/dl is only reading: (b)(6).Memory concerns:497mg/dl.Customer was complaining about her sugar and she was not complaining about the meter.She wanted to know what to do for such high blood glucose; the day before she had 600 mg/dl (fasting) and doctor had not returned her phone call.Customer daughter stated that , " she would call (b)(4) back if she took her mother to the hospital.Customer did not want to go through the meter to get all the other data so only have today's blood glucose of 497mg/dl.Customer did not want a new meter or strips; she will call us after she speaks with md.

• 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: 6529540
• Report Number: 1000113657-2017-00755
• Device Sequence Number: 840399
• Product Code: NBW
• UDI-Device Identifier: 00096295126600
• UDI-Public: (01)00096295126600
• 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): 04/28/2017

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 Expiration Date: 04/25/2018
• Device Model Number: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MT2149
• 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: 04/05/2017
• Initial Report FDA Received Date: 04/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SECOND THERAPY