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

Model Number	TRUETRACK
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Codes	Elevated ketones/Diabetic Ketoacidosis (2364); Shaking/Tremors (2515)
Date of Event	05/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not yet returned for evaluation.Most likely underlying root cause: mlc-18- user has high glucose value.(b)(4).Note: manufacturer contacted customer on (b)(6) 2018 in a follow-up call to ensure the customer's condition since the initial call; customer's condition had improved and he did not currently have any diabetic symptoms.Customer had been taken to the er on (b)(6) 2018 and he was admiited to the hospital.The customer's blood glucose test result when admitted was in the 500's, and on day of follow-up call are around 235 - 285 mg/dl.The diagnosis was diabetic ketoacidosis.The customer was given regular insulin - started at 8 units, then increased to 11 units and then to 13 units.Customer was also given blood pressure and nausea medications via iv.Customer is currently in the hospital at time of follow-up call.No additional blood tests were performed using the truetrack meter.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 initially reported complaint for being unable to obtain a blood glucose test result.Sister is calling on behalf of the customer.Customer was instructed to insert code chip into the meter and a back to back blood test was performed by the customer non-fasting that produced test results of hi and hi using truetrack meter.Sister stated the customer had taken fast acting insulin about 20 minutes prior to the back to back tests that were performed during the call.Sister stated the customer was sleepy and that he was also shaky.Sister stated she would take the customer to the hospital.

• Brand Name: TRUETRACK
• Common Device Name: BLOOD GLUCOSE SYSTEM
• Manufacturer (Section D): TRIVIDIA HEALTH, INC.; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 7560722
• Report Number: 1000113657-2018-00608
• Device Sequence Number: 11333156
• Product Code: NBW
• UDI-Device Identifier: 00050428264706
• UDI-Public: (01)00050428264706
• Combination Product (Y/N): N
• Initial Reporter State: OH
• PMA/510(K) Number: K032657
• 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): 06/01/2018

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: 04/30/2020
• Device Model Number: TRUETRACK
• Device Catalogue Number: A4H01-81
• Device Lot Number: RU5191
• 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: 05/07/2018
• Initial Report FDA Received Date: 06/01/2018
• 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