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

Model Number STRIP, TMX HNO 50CT 24/CS MG/DL

Device Problem Low Test Results (2458)

Patient Problem No Code Available (3191)

Event Date 01/09/2021

Event Type  Injury  

Manufacturer Narrative

Internal report reference number: (b)(4).Meter was returned for evaluation; no defect was detected.Test strips were not returned for evaluation.Most likely underlying root cause: mlc-055: user had an inaccurate reference: competitor¿s meter: the end user is comparing results obtained from trividia¿s bgm system to the results from a competitor¿s bgm system.Note: manufacturer contacted customer several follow-up calls to ensure the replacement products resolved the initial concern - unable to establish contact with customer at this time.

Event Description

Consumer reported complaint for low blood glucose test results.The customer is concerned with tests results from all the results obtained.The expected fasting blood glucose test result range is 140-180mg/dl.The customer did not report symptoms at the time of the call.Medical attention is not reported as a result of the actual blood glucose results.The product is stored according to specification in the bedroom.During the call a back to back blood test was not performed by the customer.The test strip open vial date is 1/17/2021.The meter memory was reviewed for previous test result history.(b)(6).

• Brand Name: TRUE METRIX
• Type of Device: SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER
• Manufacturer (Section D): TRIVIDIA HEALTH INC; 2400 nw 55th court; fort lauderdale FL 33309
• Manufacturer Contact: karen devincent ; 2400 nw 55th court; fort lauderdale, FL 33309
• MDR Report Key: 11325028
• MDR Text Key: 234935555
• Report Number: 1000113657-2021-00109
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00021292007836
• UDI-Public: (01)00021292007836
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140100
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 02/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/14/2022
• Device Model Number: STRIP, TMX HNO 50CT 24/CS MG/DL
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MX4324S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2021
• Distributor Facility Aware Date: 01/18/2021
• Date Manufacturer Received: 01/18/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization