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

Model Number KIT, WALGREENS TMX METERMG/DL #348013

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hyperglycemia (1905); Coma (2417)

Event Date 07/11/2022

Event Type  Injury  

Manufacturer Narrative

Internal report reference number: (b)(4).Adverse event report is being submitted due to customer seeking medical attention due to symptoms related to diabetes.Customer did not report a complaint associated with the products.Meter and test strips were not returned for evaluation.Manufacturer contacted customer in several follow-up calls to ensure the initial concern is resolved - unable to establish contact with customer at this time.

Event Description

Consumer called for assistance with performing a blood test.Customer stated she has not used the true metrix meter in a while.The customer feels well and did not report any symptoms.The customer stated that she had been hospitalized on (b)(6) 2022 due to a diabetic coma.Customer's blood glucose test result when at the hospital had been 100 mg/dl.The diagnosis was hyperglycemia and diabetic coma.Customer did not disclose further information.During the call, a back to back blood test was not performed by the customer.The customer's tests strips are expired: test strip lot manufacturer¿s expiration date is 08/31/2021; open vial date and storage were not disclosed.The customer was going to purchase new test strips.Customer is not alleging product defect.

• 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: 15187211
• MDR Text Key: 297495909
• Report Number: 1000113657-2022-00437
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00021292007690
• UDI-Public: (01)00021292007690
• 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: 08/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2021
• Device Model Number: KIT, WALGREENS TMX METERMG/DL #348013
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MW4147S
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/14/2022
• Date Manufacturer Received: 07/14/2022
• 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