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

Model Number	TRUEMETRIX
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	06/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not returned for evaluation.Customer declined replacement product at this time.Product is working as designed.Most likely underlying root cause: mlc-18- user has high glucose value.Test strip udi# (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; at follow- up call, customer reported that on (b)(6) 2018, after the initial call, he had gone to his primary doctor because he had been receiving the e-5 error message and was unable to obtain a reading.The customer's blood glucose test result when at the doctor's office was 610 mg/dl fasting.The diagnosis was hyperglycemia.Customer had his insulin adjusted on a sliding scale while at the office to lower his blood sugar; his dosage of lantus was increased.Customer had returned home the same day.Additional blood test performed using the truemetrix meter produced test result of 157 mg/dl fasting.The customer did not report any symptoms at time of follow-up call.
Event or Problem Description
Consumer reported complaint for e-5 error code.Pharmacist is calling on behalf of the customer.The e-5 error occurred as soon as the blood sample was absorbed.Customer had performed six blood tests in a row and was not able to obtain a result.Customer was using proper testing technique.The test strip lot manufacturer's expiration date is 05/24/2019 and open vial date was undisclosed.The customer declined to perform a blood test during the call on (b)(6) 2018.The customer feels well and did not report any symptoms.Pharmacist will take customer to his doctor in order to get a reading and verify what course of action needs to be taken.

• 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: 7639237
• Report Number: 1000113657-2018-00685
• Device Sequence Number: 1556060
• Product Code: NBW
• UDI-Device Identifier: 00052569138557
• UDI-Public: (01)00052569138557
• Combination Product (Y/N): N
• PMA/510(K) Number: K140100
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/26/2018

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: 05/24/2019
• Device Model Number: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MU2692
• 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: 06/01/2018
• Initial Report FDA Received Date: 06/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1