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

Model Number	TRUBALANCE
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(manufacturer narrative = t, corrected data = f) internal report # 01509480.Product not yet 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.
Event or Problem Description
Consumer reported complaint for high blood glucose test results.The customer is concerned with test results from results obtained of 258 (non-fasting) and 239 (fasting) mg/dl.The customer's expected fasting blood glucose test result range is 160 - 175 mg/dl and her non-fasting blood glucose test result range is 190 - 200 mg/dl.At the time of the call the customer felt well and did not report any symptoms.Customer stated that on (b)(6) 2017, she had obtained a result of 258 non-fasting and that she went straight to the er.Customer stated when she arrived at the er she was at 133 mg/dl non-fasting.Customer did not mention if she took medication before going to the hospital.Customer did not receive any treatment and she went home on the same day.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 11/25/2019 and open vial date is 08/29/2017.The meter memory was reviewed for previous test result history: 1:258mg/dl (b)(6) 2017 09:36 am fasting:no.2:189mg/dl (b)(6) 2017 01:09 pm fasting:yes.3:186mg/dl (b)(6) 2017 09:30 am fasting:yes.4:239mg/dl (b)(6) 2017 07:30 am fasting:yes.5:123mg/dl (b)(6) 2017 09:30 am fasting:yes.Memory concerns:customer is concerned with 239 fasting and 258 non-fasting.Had customer run a control test and she obtained a 247mg/dl (out of range) range: 152-232mg/dl.

• Brand Name: TRUBALANCE
• Common Device Name: BLOOD GLUCOSE SYSTEM
• Manufacturer (Section D): TRIVIDIA HEALTH, INC.; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 6903695
• Report Number: 1000113657-2017-01758
• Device Sequence Number: 19045455
• Product Code: NBW
• UDI-Device Identifier: 00021292007959
• UDI-Public: (01)00021292007959(17)191125(10)BU5102
• Combination Product (Y/N): N
• Initial Reporter State: PR
• PMA/510(K) Number: K090495
• 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): 09/29/2017

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: 11/25/2019
• Device Model Number: TRUBALANCE
• Device Catalogue Number: H4H01-81
• Device Lot Number: BU5102
• 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: 09/05/2017
• Initial Report FDA Received Date: 09/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1