MAUDE Adverse Event Report: TRIVIDIA HEALTH, INC. N/A; BLOOD GLUCOSE SYSTEM

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hyperglycemia (1905); Hypovolemic Shock (1917); Polydipsia (2604)
Date of Event	06/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not returned for evaluation.No replacement product needed at this time.Customer will get another device.Most likely underlying root cause: mlc-18- user has high glucose value.
Event or Problem Description
Customer called to request a replacement for a blood glucose meter.Customer dropped the meter and it broke.Customer threw the meter away.No meter available at the time of the call.Customer didn't have any complaint about the performance of the product.The expected fasting blood glucose test result range is undisclosed.The product storage location is undisclosed.The test strip lot manufacturer's expiration date is 09/28/2019 and open vial date is undisclosed.Customer was not feeling any symptoms of low or high blood sugar at the time of the call.Customer report a previous symptoms and medical attention.On (b)(6) 2018 customer was feeling nauseous, weak and thirsty.Customers blood sugar read above 800mg/dl fasting and went to the hospital.Customer was feeling high blood sugar symptoms but cannot recall anything done in the hospital.All customer remembers is that she was given insulin to bring the blood sugar down during her stay in the hospital.Per hospital's instruction: customer was on 10 units at night of lantus, customer is taking more units but does not remember how much more at night.Customer only remembers that her blood sugar was at 300mg/dl fasting when she left on (b)(6) 2018.

• Brand Name: N/A
• Common Device Name: BLOOD GLUCOSE SYSTEM
• Manufacturer (Section D): TRIVIDIA HEALTH, INC.; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 7691692
• Report Number: 1000113657-2018-00759
• Device Sequence Number: 806105
• Product Code: NBW
• UDI-Device Identifier: 00021292007867
• UDI-Public: (01)00021292007867(17)190928(10)MV2835
• Combination Product (Y/N): N
• PMA/510(K) Number: UNKNOWN
• 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): 07/16/2018

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 Model Number: N/A
• Device Catalogue Number: UNKNOWM
• Device Lot Number: MV2835
• 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: 06/20/2018
• Initial Report FDA Received Date: 07/16/2018
• 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