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

Model Number STRIP, TMX HMN 50CT24/CASE MG/DL

Device Problem Insufficient Information (3190)

Patient Problems Hypoglycemia (1912); Confusion/ Disorientation (2553); Speech Disorder (4415)

Event Date 09/06/2023

Event Type  Injury  

Manufacturer Narrative

Internal report reference number: (b)(4).B2: adverse event report is being submitted due to customer contacting paramedics due to symptoms related to diabetes.Meter and test strips were not returned for evaluation.Lot number of test strips customer was using at time of adverse event in (b)(6) is not available; retention testing had been performed using test strips from the same lot of test strips customer reported complaint of e-3 ( (b)(4), passed within specifications).Most likely underlying root cause: mlc-062: user had poor technique.Note: 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 initially reported complaint for error message (e-3).Niece is calling on behalf of the customer.At the time of the call the customer feels well and did not report any symptoms.During the call, customer reported that in (b)(6) 2023 she had slurred speech and had been very confused (could not verify exact date).Due to her confusion at the time, customer does not recall if she was getting an error on the true metrix air meter when trying to use it or how she had been attempting to test.Paramedics had been called; when the paramedics arrived and tested the customer's blood glucose, they had obtained a result of 30 mg/dl (undisclosed if fasting or non-fasting).The diagnosis was low blood glucose and the paramedics had given the customer glucose gel and had her eat a peanut butter and jelly sandwich.Customer's blood glucose had gone up to 300 mg/dl non-fasting.Customer was not taken to the hospital and was advised to follow-up with her primary care physician.Niece advised that the previous vial of strips that the customer was using in august was finished and she does not know the lot number of the test strips customer was using at the time.Customer currently using test strip lot zb5216s and obtaining the error message of e-3.

• 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: 17834199
• MDR Text Key: 324478297
• Report Number: 1000113657-2023-00487
• Device Sequence Number: 1
• Product Code: NBW
• 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: Replace
• Type of Report: Initial
• Report Date: 09/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: STRIP, TMX HMN 50CT24/CASE MG/DL
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 09/06/2023
• Date Manufacturer Received: 09/06/2023
• 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