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

Model Number STRIP, SUNMARK TMX 100CTMG/DL

Device Problem Image Display Error/Artifact (1304)

Patient Problems Lethargy (2560); Polydipsia (2604)

Event Date 09/26/2022

Event Type  Injury  

Manufacturer Narrative

Internal report reference number: (b)(4).Adverse event report is being submitted due to symptoms related to diabetes: lethargy and thirst.Meter and test strips were not returned for evaluation.Retention testing was performed using test strips from the same lot.Retention strip lot tested within specifications.Most likely underlying root cause: user applied blood to strip before inserting strip into meter.Note: manufacturer contacted customer in several follow-up calls to ensure the customer's condition had improved and that the replacement products resolved the initial concern - unable to establish contact with customer at this time.

Event Description

Consumer reported complaint for error message (e-3).Customer stated they had obtained the e-3 error message with two vials of the same lot number of test strips.Customer stated the e-3 error occurred when the test strips were inserted into the true metrix meter.At the time of the call, the customer reported symptoms of lethargy and thirst; medical attention was not needed at the time.During the call, a blood test was performed by the customer and produced e-3 error using true metrix meter.The product is stored according to specification in the bedroom.The test strip lot manufacturer¿s expiration date is 01/22/2024 and test strips were opened three weeks prior to call.

• 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: 15650346
• MDR Text Key: 302195334
• Report Number: 1000113657-2022-00558
• 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: 10/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/22/2024
• Device Model Number: STRIP, SUNMARK TMX 100CTMG/DL
• Device Catalogue Number: RE4H01-81
• Device Lot Number: ZA4856S
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 09/26/2022
• Date Manufacturer Received: 09/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other