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

Model Number STRIP, TMX HEB 30CT24/CASE MG/DL

Device Problem Image Display Error/Artifact (1304)

Patient Problems Muscle Weakness (1967); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/07/2022

Event Type  malfunction  

Event Description

Consumer reported complaint for error messages (e-2 and e-5).The product is stored according to specification in the bedroom.The test strip lot manufacturer¿s expiration date is 08/31/2023 and test strips were opened one week prior to call.During the call, a blood test was performed by the customer fasting and produced test result of 140 mg/dl using true metrix go meter; the customer was satisfied with the result obtained.At the time of the call the customer reported symptoms of feeling weak and back pressure.Customer stated he was going to contact his doctor.

Manufacturer Narrative

Internal report reference number: (b)(4).Adverse event report is being submitted due to customer contacting doctor due to symptoms.Meter was returned for evaluation.Product testing was performed and no defect found.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: mlc-062: user had poor technique.Note 1: manufacturer contacted customer in a follow-up call on 08-apr-2022 to ensure that the customer's condition had improved - able to establish contact with customer who stated his condition had improved and he did not currently have any diabetic symptoms.Customer stated he had contacted his doctor after the initial call.Customer stated that the doctor had prescribed him gi medication (not related to diabetes).No further information was provided.Customer stated he had obtained a blood glucose test result of 125 mg/dl fasting using the true metrix go meter; customer was satisfied with the result obtained.Note 2: manufacturer contacted customer in a follow-up call on 20-apr-2022 to ensure the replacement products resolved the initial concern - able to establish contact with customer who stated replacement products resolved initial concern.

• 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: 14288626
• MDR Text Key: 290964977
• Report Number: 1000113657-2022-00263
• 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: Replace
• Type of Report: Initial
• Report Date: 05/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2023
• Device Model Number: STRIP, TMX HEB 30CT24/CASE MG/DL
• Device Catalogue Number: RF4H01-01
• Device Lot Number: ZY4679S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2022
• Distributor Facility Aware Date: 04/07/2022
• Date Manufacturer Received: 04/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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