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

Model Number	TMETRIX PR
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report # (b)(4).Returned meter and returned test strips evaluated with no defects found.Most likely underlying root cause: mlc-18- user has high glucose value test strip udi# (b)(4).Note: manufacturer contacted customer (several attempts) in a follow-up call in order to ensure the customer's condition since the initial call - unable to establish contact with the customer at this time.Product notification letter sent to customer to contact customer care.
Event or Problem Description
Customer states the meter is reading hi display and only concerned with this.Nurse calling on behalf of facility states that meter was reading hi on their patient.Nurse states that she cannot disclose how customer is feeling at time of call because that patient was not with nurse at time of call.Nurse declined to go through history of meter due to her having other patients to attend to.Customer did state because they were only receiving hi on meter doctor is having customer go to emergency room.Customer states their normal fasting range is 70 mg/dl-100mg/dl fasting.The product is stored according to specification in the medicine cabinet.During the call on (b)(6) 2019, a blood test was not performed by the customer.The test strip lot manufacturer's expiration date is 10/25/2019 and open vial date is (b)(6) 2019.

• Brand Name: TMETRIX PR
• Common Device Name: BLOOD GLUCOSE SYSTEM
• Manufacturer (Section D): TRIVIDIA HEALTH, INC.; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 8343704
• Report Number: 1000113657-2019-00137
• Device Sequence Number: 14058147
• Product Code: NBW
• UDI-Device Identifier: 10612479210254
• UDI-Public: (01)10612479210254
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Nurse
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 02/15/2019

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 Model Number: TMETRIX PR
• Device Catalogue Number: RE4H01P-43
• Device Lot Number: MV2867
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2019
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2019
• Initial Report FDA Received Date: 02/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1