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

Model Number KIT, AIR CVS TMX METERMG/DL

Device Problem High Test Results (2457)

Patient Problems Diarrhea (1811); Fatigue (1849); Hyperglycemia (1905); Blurred Vision (2137); Vomiting (2144)

Event Date 03/24/2022

Event Type  Injury  

Manufacturer Narrative

Internal report reference number: (b)(4).Test strips were not returned for evaluation.Meter was returned for evaluation - product testing was performed and no defect found.Retention testing was performed using test strips from the same lot.Retention strip lot tested within specifications.Most likely underlying root cause: mlc-018: user has high glucose value.Manufacturer contacted customer in a follow-up call on (b)(6) 2022 to ensure the customer's condition had improved - able to establish contact with customer who stated she still had blurry vision and was very tired.Customer contacted her physician that morning and has an upcoming appointment.Customer had performed blood test today using the true metrix air meter and had obtained result of hi.Manufacturer contacted customer in a follow-up call (b)(6) 2022 to ensure the customer's condition had improved - able to establish contact with customer who stated she was now experiencing shortness of breath.Customer had gone to her doctor's appointment that day; doctor had recommended a higher dosage of metformin, glipizide and insulin.Manufacturer contacted customer in a follow-up call on (b)(6) 2022 to ensure the customer's condition had improved - able to establish contact with customer who stated the symptoms she is now having (diarrhea and throwing up) are due to the metformin 2000 mg she is taking.Customer stated she is stopping the metformin since that is what is making her so sick and was going to continue the insulin only.Customer had received the replacement products and stated her blood glucose test result was 358 mg/dl fasting.Manufacturer contacted customer in several follow-up calls to ensure the replacement products resolved the initial concern - unable to establish contact with customer at this time.

Event Description

Consumer reported complaint for the true metrix meter not turning on when a test strip was inserted, high and "hi" blood glucose test result (reported at (b)(6) 2022 follow-up).The customer is concerned with test results from results obtained of 465, 474, 479, 537 and 472 mg/dl.The customer does not know their expected blood glucose test result range.At the time of the call the customer reported having blurry vision.Customer had contacted paramedics earlier that day due to the high blood glucose test results.The paramedics had tested the customer's blood glucose and had obtained hi.The customer had been diagnosed with hyperglycemia and treated with iv and insulin.Customer was advised to follow-up with her physician.Medical attention is not reported as a result of the actual blood glucose results (and reported symptoms).During the call, a blood test was performed by the customer non-fasting and produced test result of 465 mg/dl using true metrix meter; the customer was not satisfied with the result obtained.The product is stored according to specification in the bedroom.The test strip lot manufacturer¿s expiration date is 05/31/2023 and open vial date is 03/11/2022.The meter memory was reviewed for previous test result history: result 1 : 465 mg/dl date: (b)(6) time: 4:34 pm non-fasting.Result 2 : 474 mg/dl date: (b)(6) time: 4:09 pm fasting.Result 3 : 479 mg/dl date: (b)(6) time: 11:41 am fasting.Result 4 : 537 mg/dl date: (b)(6) time: 7:23 am non fasting.Result 5 : 472 mg/dl date: (b)(6) time: 1:48 am fasting.

• 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: 14164379
• MDR Text Key: 294619733
• Report Number: 1000113657-2022-00226
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00021292007720
• UDI-Public: (01)00021292007720
• 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: Consumer
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 04/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2023
• Device Model Number: KIT, AIR CVS TMX METERMG/DL
• Device Catalogue Number: REA4H01-01
• Device Lot Number: ZY4567S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2022
• Distributor Facility Aware Date: 03/24/2022
• Date Manufacturer Received: 03/24/2022
• 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): Required Intervention