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

Model Number	STRIP, TRUE METRIX PRO50CT MG/DL
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	Dizziness (2194)
Date of Event	05/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Meter was not returned for evaluation.Test strips were returned for evaluation.No defect was detected.Most likely underlying root cause: mlc-14: insufficient blood sample applied to strip (user).Adverse event report is being submitted due to symptoms related to diabetes -dizziness note: manufacturer contacted customer in a follow-up call on 26-may-2020 to ensure that the customer's condition improved - able to establish contact with customer and stated still feeling dizzy.
Event or Problem Description
Consumer reported complaint for e-2 error code.Customer was not using the proper testing techniques and was using truemetrix pro test strips with truemetrix meter.During the call, a blood test was performed by the customer fasting and produced test result of 112 mg/dl using truemetrix meter.After troubleshooting, the customer is satisfied the product is working as intended and declines a replacement.The product is stored according to specification in the living area.The test strip lot manufacturer¿s expiration date is 07/25/2021 and open vial date is 05/10/2020.At the time of the call the customer reported slight dizziness, medical attention was not needed at the time of the call.

• 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: 10159238
• Report Number: 1000113657-2020-00402
• Device Sequence Number: 11729132
• Product Code: NBW
• UDI-Device Identifier: 00021292007867
• UDI-Public: (01)00021292007867
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 06/16/2020

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: 07/25/2021
• Device Model Number: STRIP, TRUE METRIX PRO50CT MG/DL
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MW4074S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2020
• Distributor Facility Aware Date: 05/18/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/18/2020
• Initial Report FDA Received Date: 06/16/2020
• 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