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

Model Number STRIP, WGN TMX 30CT 24/CASE MG/DL

Device Problem Image Display Error/Artifact (1304)

Patient Problems Dizziness (2194); Numbness (2415); Paresthesia (4421)

Event Date 01/06/2022

Event Type  Injury  

Event Description

Consumer reported complaint for unknown error messages.During the call, a blood test was performed by the customer fasting and produced test result of 93 mg/dl using true metrix go meter.At the time of the call, the customer reported symptoms of tingling and numbness in her fingers and feeling dizzy.Medical attention was not needed at the time.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).Adverse event report is being submitted due to symptoms related to diabetes: dizziness, numbness and tingling in fingers.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.

Manufacturer Narrative

Sections with additional information as of 22-march-2022: h6: updated fda's type of investigation, investigation findings, and investigation conclusions.H10: meter and strips were not returned for evaluation.Retention testing was performed using test strips from the same lot.Retention strips tested within specifications.Most likely underlying root cause: mlc-028: there was not enough information to determine the mlurc.

• 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: 13415126
• MDR Text Key: 286936087
• Report Number: 1000113657-2022-00042
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00021292009120
• UDI-Public: (01)00021292009120
• 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
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2023
• Device Model Number: STRIP, WGN TMX 30CT 24/CASE MG/DL
• Device Catalogue Number: RF4H01-01
• Device Lot Number: ZY4520S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 01/06/2022
• Date Manufacturer Received: 02/24/2022
• 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