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

Model Number STRIP, TMX CVS 100CT12/CASE MG/DL

Device Problem High Test Results (2457)

Patient Problems Fatigue (1849); Hyperglycemia (1905); Urinary Tract Infection (2120); Blurred Vision (2137); Urinary Frequency (2275); Polydipsia (2604)

Event Date 09/15/2022

Event Type  Injury  

Manufacturer Narrative

Internal report reference number: (b)(4).Meter and test strips were not returned for evaluation.Note: manufacturer contacted customer in a follow-up call on 19-sep-2022 to ensure that the customer's condition had improved - able to establish contact with customer who stated she did not currently have any diabetic symptoms.Customer had gone to the emergency room on (b)(6) 2022 and had also gone to her doctor (a previous scheduled appointment).At the er the customer was diagnosed with high blood glucose and a uti; customer was treated with fluids.Customer stated that she continued to use the true metrix air meter and had obtained a result of 414 mg/dl.Customer stated she believed the product was working as intended and declined replacement.

Event Description

Consumer reported complaint for hi blood glucose test results.Mother is calling on behalf of the customer.The customer is concerned with test results from results obtained of hi.At the time of the call the customer reported symptoms of blurry vision, tiredness, thirsty, and needing to urinate often.Medical attention was not needed at the time; customer has a doctor's appointment the following day.The customer¿s expected blood glucose test result range was not disclosed.During the call, a back to back blood test was not performed by the customer.The test strip lot manufacturer¿s expiration date is 01/13/2024; customer had obtained the true metrix air meter that day.The meter memory was not reviewed for previous test result history.

Manufacturer Narrative

Sections with additional information as of 31-oct-2022: 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 passed within specifications.Most likely underlying root cause: mlc-018: user has high glucose value.

• Brand Name: TRUE METRIX AIR
• 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: 15580786
• MDR Text Key: 301567397
• Report Number: 1000113657-2022-00536
• 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: K150052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/31/2022

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 Expiration Date: 01/13/2024
• Device Model Number: STRIP, TMX CVS 100CT12/CASE MG/DL
• Device Catalogue Number: REA4H01-01
• Device Lot Number: ZA4839S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 09/15/2022
• Initial Date Manufacturer Received: 09/15/2022
• Initial Date FDA Received: 10/11/2022
• Supplement Dates Manufacturer Received: 10/11/2022
• Supplement Dates FDA Received: 10/31/2022
• 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