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

Model Number STRIP, TRUE METRIX 50CTMG/DL

Device Problem High Test Results (2457)

Patient Problems Hyperglycemia (1905); Dizziness (2194)

Event Date 11/21/2022

Event Type  Injury  

Event Description

Consumer reported complaint for hi blood glucose test results.At the time of the call the customer stated she was not feeling well and was feeling dizzy.Customer stated that she was going to seek medical attention and contact her doctor.No further information, including meter serial number and test strip lot number, was able to be obtained.

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.Manufacturer contacted customer in a follow-up call on 01-dec-2022 to ensure that the customer's condition had improved and that the initial concern was resolved - able to establish contact with customer who stated her condition had improved and she did not currently have any diabetic symptoms.Customer reported medical attention since the last call, stating she had gone to the emergency room on (b)(6) 2022.Customer's blood glucose test result at the emergency room had been 500 mg/dl (fasting/non-fasting not disclosed).The diagnosis was hyperglycemia and customer had been treated with insulin.Customer had been discharged the same day; customer's blood glucose test result upon discharge had been 140 mg/dl (fasting/non-fasting not disclosed).Customer stated she is comfortable with the glucose readings from the product.

• 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: 15970911
• MDR Text Key: 305375941
• Report Number: 1000113657-2022-00650
• Device Sequence Number: 1
• Product Code: NBW
• 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: Other
• Type of Report: Initial
• Report Date: 12/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: STRIP, TRUE METRIX 50CTMG/DL
• Device Catalogue Number: RE4H01-81
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 11/21/2022
• Date Manufacturer Received: 11/21/2022
• 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