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

Model Number	TRUBALANCE
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Codes	Blurred Vision (2137); Urinary Frequency / Polyuria (2275); Polydipsia (2604)
Date of Event	01/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Returned meter evaluated with no defect found.Test strips not returned for evaluation.Most likely underlying root cause: (b)(4) - user has high glucose value test strip udi# (b)(4).Note: manufacturer contacted customer on (b)(4) 2018 in a follow-up call in order to ensure the customer's condition since the initial call; customer condition improved.No symptoms or medical attention reported since the original call.Customer satisfied with the replacement product.
Event or Problem Description
Consumer reported complaint for e-3 error; customer also stated the meter read hi.Customer was more concerned that the meter read e-3 than hi.The customer stated that she does not have an expected blood glucose test result range; customer stated she usually tests hi or in the 500s mg/dl.At the end of the call on (b)(6) 2018, the customer stated she was going to seek medical intervention due to symptoms of increased thirst, increased urination and blurry vision.The product is not stored according to specification and is stored in the kitchen.The customer also stated she had poured the test strips out of the container into a plastic bag.The test strip lot manufacturer's expiration date is 02/22/2020 and open vial date at time of call is one week.During the call on (b)(6) 2018, a blood test was performed by the customer using a new vial of test strips with the same lot number and produced test result of hi using truebalance meter.The meter memory was reviewed for previous test result history: result 1 : hi mg/dl date: (b)(6) 2018 time10:57am fasting.Result 2 : hi mg/dl date: (b)(6) 2018 time:4:28pm fasting.Result 3 : hi mg/dl date: (b)(6) 2017 time:11:57am fasting.Result 4 :513mg/dl date: (b)(6) 2017 time:5:05am fasting.Result 5 :337mg/dl date: (b)(6) 2017 time:9:07am fasting.Customer states called stating that the meter reads e-3.Customer also states that the meter read hi.Customer poured her test strips into a plastic bag, instructed customer that, that was the reason for her e-3 but because her meter read hi i needed to replace all her products.Customer is currently having symptoms of high blood sugar - increased thirst, increased urination and blurry vision.Customer states that she does not have a normal range as she usually test hi, or in the 500's.Customer is more concern that the meter read e-3 than hi.

• 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: 7223047
• Report Number: 1000113657-2018-00108
• Device Sequence Number: 1367902
• Product Code: NBW
• UDI-Device Identifier: 00021292003135
• UDI-Public: (01)00021292003135
• 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): 01/26/2018

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: 02/22/2020
• Device Model Number: TRUBALANCE
• Device Catalogue Number: H4H01-81
• Device Lot Number: BU5154
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2018
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2018
• Initial Report FDA Received Date: 01/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1