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

Model Number METER, GO TRUE METRIXMTR ONLY TRIVIDIA MG/DL

Device Problem Image Display Error/Artifact (1304)

Patient Problems Ambulation Difficulties (2544); Cognitive Changes (2551); Speech Disorder (4415)

Event Date 07/07/2021

Event Type  Injury  

Manufacturer Narrative

Internal report reference number: (b)(4).Adverse event report is being submitted due to symptoms related to diabetes: "scared to walk and not speaking or thinking good".Meter and test strips were not returned for evaluation.Note: 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 Description

Consumer reported complaint for the true metrix go meter displayed the e-5 error message.Husband is calling on behalf of the customer.At the time of the call, husband reported that customer was not feeling well and stated that "she is scared to walk" and that "she is not speaking or thinking good." customer stated that she would seek medical intervention.Meter and test strip information was not able to be obtained.

• Brand Name: TRUE METRIX GO
• 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: 12279819
• MDR Text Key: 265136097
• Report Number: 1000113657-2021-00462
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143548
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 08/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: METER, GO TRUE METRIXMTR ONLY TRIVIDIA MG/DL
• Device Catalogue Number: RF4H01-01
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/07/2021
• Date Manufacturer Received: 07/07/2021
• 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