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

Model Number STRIP, TMX WGN 100CT 12/CS MG/DL #383569

Device Problem High Test Results (2457)

Patient Problems Hyperglycemia (1905); Muscle Weakness (1967); Blurred Vision (2137); Urinary Frequency (2275); Polydipsia (2604)

Event Date 11/21/2022

Event Type  Injury  

Manufacturer Narrative

Internal report reference number:(b)(4).Meter and test strips were not returned for evaluation.Most likely underlying root cause: mlc-018: user has high glucose value.Note 1: customer contacted manufacturer in a follow-up call on 22-nov-2022 - customer stated that she had obtained a result that day of 600 mg/dl and hi.Coordinator had spoken with customer and transferred customer's information to technician.Note 2: manufacturer contacted customer in a follow-up call on 23-nov-2022 to ensure the customer's condition had improved - able to establish contact with customer who stated she was still experiencing symptoms.Customer stated she was feeling weak and was that she was on her way to the hospital.Customer stated she had spoken with her doctor who advised she go to the hospital if she is obtaining high blood glucose test results.Note 3: manufacturer contacted customer in a follow-up call on 23-nov-2022 to ensure the customer's condition had improved - able to establish contact with customer who stated she did not currently have any diabetic symptoms.Customer stated she had gone to the hospital on (b)(6) 2022; customer's blood glucose test result when at the hospital had been 593 mg/dl.The diagnosis was high blood sugar and customer was given 10 units of insulin and fluids.The customer was discharged the same day and stated the true metrix meter was working and she was able to get her blood glucose test result down in the 300's mg/dl.Note 4: manufacturer contacted customer in a follow-up call on 30-nov-2022 to ensure the replacement products resolved the initial concern - able to establish contact with customer who stated replacement products resolved initial concern.

Event Description

Consumer reported complaint for error messages (e-2, e-3 and e-5) and hi blood glucose test results.The customer¿s expected blood glucose test result range was not disclosed.The customer reported symptoms of blurry vision , needing to urinate often, feeling thirsty and weak.Customer states that she texted the dr.But did not get a response as of yet.During the call, a blood test was performed by the customer (did not disclose fasting / non-fasting) and produced test result of hi using true metrix meter.The product is stored according to specification in the bedroom.The test strip lot manufacturer¿s expiration date is 03/28/2023 and open vial date is one week ago.The meter memory was not reviewed for previous test result history.

Manufacturer Narrative

Sections with additional information as of 12-jan-2023: h6: updated fda¿s type, findings and conclusions codes.H10: meter was not returned for evaluation.Test strips were not returned for evaluation.Retention testing was performed using test strips from the same lot.Retention strip lot tested within specifications.

• 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: 15979041
• MDR Text Key: 305490472
• Report Number: 1000113657-2022-00651
• 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,Followup
• Report Date: 01/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/28/2023
• Device Model Number: STRIP, TMX WGN 100CT 12/CS MG/DL #383569
• Device Catalogue Number: RE4H01-81
• Device Lot Number: ZY4481S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 11/21/2022
• Date Manufacturer Received: 12/20/2022
• 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): Hospitalization; Other