MAUDE Adverse Event Report: TRIVIDIA HEALTH INC TRUE METRIX; SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER

Model Number	KIT, TMX NFRS STARTERMG/DL
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Meter was returned for evaluation; no defect was detected.Test strips were returned for evaluation; no defect was detected.Most likely underlying root cause: (b)(4): user has high glucose value.Note: manufacturer contacted customer in a follow-up call on (b)(6) 2020 to ensure the replacement products resolved the initial concern, able to establish contact with customer and stated replacement product resolved initial concern.
Event or Problem Description
Consumer reported complaint for high/hi blood glucose test results.The customer is concerned with all test results obtained.The expected fasting blood glucose test result range is unknown.The customer did not report symptoms.Medical attention is reported as a result of the actual blood glucose results.Customer contacted the hospital on (b)(6) 2020 due to high blood results.Customer contacted her primary doctor today due to her blood glucose results of 391 mg/dl and the doctor advised her to take another pill.The product is stored according to specification in the dining room.During the call a back to back blood test was not performed by the customer.The test strip lot manufacturer¿s expiration date is 10/31/2019 (expired) and open vial date is august 2020.The meter memory was reviewed for previous test result history.Result 1: hi, date: (b)(6) 2020, time: 8:08 pm, unknown if fasting or non-fasting.Result 2: 600 mg/dl, date: (b)(6) 2020, time: 8:08 pm, unknown if fasting or non-fasting.

• Brand Name: TRUE METRIX
• Common Device Name: SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER
• Manufacturer (Section D): TRIVIDIA HEALTH INC; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 10508196
• Report Number: 1000113657-2020-00659
• Device Sequence Number: 19616487
• Product Code: NBW
• UDI-Device Identifier: 00021292006075
• UDI-Public: (01)00021292006075
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K140100
• 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): 09/09/2020

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: 10/31/2019
• Device Model Number: KIT, TMX NFRS STARTERMG/DL
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MV2876
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2020
• Distributor Facility Aware Date: 08/12/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/12/2020
• Initial Report FDA Received Date: 09/09/2020
• 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: Required Intervention