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	Failure to Power Up (1476)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/07/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Meter and test strips were not returned for evaluation.Most likely underlying root cause: mlc-42: dead battery.Note: manufacturer contacted customer in a follow-up call to ensure the replacement products resolved the initial concern - unable to establish contact with customer at this time.Product notification letter sent to contact customer care.
Event or Problem Description
Consumer reported complaint for dead meter.Blood glucose test results.Hayword/nurse/local clinic is calling on behalf of the customer.The expected fasting blood glucose test result range is undisclosed.The customer did not report symptoms.Medical attention is reported as a result of the actual blood glucose results.The product storage location is undisclosed.During the call a back to back blood test was not performed by the customer.The test strip lot manufacturer¿s expiration date is 11/20/2021 and open vial date is undisclosed.The meter memory was not reviewed for previous test result history.

• 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: 10787868
• Report Number: 1000113657-2020-00807
• Device Sequence Number: 3630156
• Product Code: NBW
• UDI-Device Identifier: 00021292006075
• UDI-Public: (01)00021292006075
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 11/04/2020

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 Model Number: KIT, TMX NFRS STARTERMG/DL
• Device Catalogue Number: RE4H01-81
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 10/07/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/07/2020
• Initial Report FDA Received Date: 11/04/2020
• 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: Other