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

Model Number KIT, TRUE METRIX METERMG/DL

Device Problem High Test Results (2457)

Patient Problem Insufficient Information (4580)

Event Date 11/04/2022

Event Type  Injury  

Event Description

Consumer reported complaint for hi blood glucose test results.The customer is concerned with test results from hi; customer stated he had tested using another device and had obtained a result of 575 mg/dl.Customer was experiencing symptoms at the time but did not disclose what they were.Customer declined to call for medical intervention or use his life alert, as he did not want to go to the hospital.Customer stated he would contact a friend across the street.Customer was not able to provide product information.Coordinator had initially spoken with customer and transferred customer's information to technician.Technician was unable to contact the customer via telephone, no further information was able to be obtained.

Manufacturer Narrative

Internal report reference number: (b)(4).Outcomes attributed to adverse event: adverse event report is being submitted due to symptoms related to diabetes (undisclosed).Meter and test strips were not returned for evaluation.Most likely underlying root cause: mlc-018: user has high glucose value.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.

• 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: 15905522
• MDR Text Key: 304705295
• Report Number: 1000113657-2022-00621
• Device Sequence Number: 1
• Product Code: NBW
• 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: Other
• Type of Report: Initial
• Report Date: 12/02/2022

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
• Device Operator: Lay User/Patient
• Device Model Number: KIT, TRUE METRIX METERMG/DL
• Device Catalogue Number: RE4H01-81
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 11/04/2022
• Initial Date Manufacturer Received: 11/04/2022
• Initial Date FDA Received: 12/02/2022
• 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