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

Model Number	STRIP, RLN TMX 100CTMG/DL
Medical Device Problem Code	Image Display Error/Artifact (1304)
Health Effect - Clinical Code	Fatigue (1849)
Date of Event	02/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Meter and test strips were not returned for evaluation - customer declined replacement.Adverse event report is being submitted due to symptoms related to diabetes: tired.Note 1: manufacturer contacted customer in follow-up call on 18-mar-2021 to inform customer test strip lot number provided at initial call had been expired at the time; customer stated she was no longer using the expired test strips.No information regarding the customer's condition had been obtained.Note 2: manufacturer contacted customer in several follow-up calls to ensure the customer's condition had improved and that the initial concern is resolved - unable to establish contact with customer at this time.
Event or Problem Description
Consumer reported complaint for error message (e-3).The customer was not using the proper testing technique (blood sample on test strip when inserted into truemetrix meter).The product is stored according to specification in the bedroom.The test strip lot manufacturer¿s expiration date is 09/21/2020 (expired) and open vial date is 02/2021.During the call, a blood test was performed by the customer non-fasting using the expired test strips and produced test result of 246 mg/dl using truemetrix meter; customer was satisfied with the result obtained.At the time of the call, the customer reported feeling tired; medical attention was not needed at the time.

• 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: 11542832
• Report Number: 1000113657-2021-00193
• Device Sequence Number: 11504598
• Product Code: NBW
• UDI-Device Identifier: 00021292012236
• UDI-Public: (01)00021292012236
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 03/22/2021

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/21/2020
• Device Model Number: STRIP, RLN TMX 100CTMG/DL
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MW3229S
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/23/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/23/2021
• Initial Report FDA Received Date: 03/22/2021
• 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