MAUDE Adverse Event Report: TRIVIDIA HEALTH, INC. TRUEMETRIX; BLOOD GLUCOSE SYSTEM

Model Number	TRUEMETRIX
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	12/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Returned meter and returned test strips evaluated with no defects found.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 udi# (b)(4).Note: manufacturer contacted customer on (b)(6) 2018, in a follow-up call to ensure that the replacement products resolved the initial concern; customer stated that the replacement product is working to their satisfaction and they have not had any medical intervention or symptoms since the last call.
Event or Problem Description
Consumer reported complaint for erratic blood glucose test results.Daughter is calling on behalf of the customer.The customer is concerned with tests results from back to back blood tests of 408 and 355 mg/dl.Customer was not concerned with high results.The customer's expected fasting blood glucose test result range is 170 - 210 mg/dl.At the time of the call the customer felt well and did not report any symptoms.A past adverse event was reported.On (b)(6) 2018, the customer had not been able to stand and the ambulance had been called.At the hospital the customer was diagnosed with hyperglycemia and was given iv fluids and an insulin drip.The customer's blood glucose test result when at the hospital was 439 mg/dl non-fasting.The customer had been hospitalized from (b)(6) 2018 - (b)(6) 2018.A new medication was suggested; customer was placed on insulin.During the call on (b)(6) 2018, a back-to-back blood test was performed by the customer fasting and produced test results of 310 mg/dl and 323 mg/dl using truemetrix meter.The product is stored according to specification in the living room.The test strip lot manufacturer's expiration date is 02/17/2020, and open vial date is (b)(6) 2018.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: 8185138
• Report Number: 1000113657-2018-01273
• Device Sequence Number: 16475527
• Product Code: NBW
• UDI-Device Identifier: 00052569138557
• UDI-Public: (01)00052569138557
• Combination Product (Y/N): N
• Initial Reporter State: SC
• PMA/510(K) Number: K140100
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 12/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/17/2020
• Device Model Number: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MV2891
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2018
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2018
• Initial Report FDA Received Date: 12/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization