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

Model Number STRIP, SUNMARK TMX 50CTMG/DL MM

Device Problem Image Display Error/Artifact (1304)

Patient Problems Hyperglycemia (1905); Nausea (1970); Lethargy (2560)

Event Date 09/27/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: case-(b)(4).Meter and test strips were not returned for evaluation.Note 1: manufacturer contacted customer in a follow-up call on 29-sep-2022 to ensure that the customer's condition had improved - able to establish contact with customer who currently was in the hospital.Customer had gone to the hospital after the initial call on 09/27/2022 due to his symptoms.The diagnosis was high blood glucose.Note 2: manufacturer contacted customer in a follow-up call on 30-sep-2022 to ensure that the customer's condition had improved - able to establish contact with customer's brother who stated customer remained in the hospital.No further information was provided.Note 3: manufacturer contacted customer in a follow-up call on 03-oct-2022 to ensure that the customer's condition had improved - able to establish contact with customer's brother who stated customer had been discharged from the hospital on 10/01/2022.Customer was currently at dialysis and not available at the time.No further information was provided.Note 4: manufacturer contacted customer in a follow-up call on 04-oct-2022 to ensure that the customer's condition had improved - able to establish contact with customer's brother who stated customer the customer was not currently experiencing any diabetic symptoms.No additional medical attention was reported.Brother stated the true metrix meter was working fine.

Event Description

Consumer reported complaint for error message (e-5).Nurse is calling on behalf of the customer.At the time of the call the customer reported feeling lethargic and nauseous; medical attention was not needed at the time.During the call, a blood test was performed by the customer and produced e-5 error using true metrix meter.The product is stored according to specification.The test strip lot manufacturer¿s expiration date is 09/30/2023 and open vial date is (b)(6) 2022.

Manufacturer Narrative

Sections with additional information as of 16-nov-2022: h6: updated fda's type of investigation, investigation findings, and investigation conclusions.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 strips tested within specifications.Most likely underlying root cause: mlc-018: user has high glucose value.

• 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: 15650861
• MDR Text Key: 302192876
• Report Number: 1000113657-2022-00562
• 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: K140100
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2023
• Device Model Number: STRIP, SUNMARK TMX 50CTMG/DL MM
• Device Catalogue Number: RE4H01-81
• Device Lot Number: ZA4703S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 09/27/2022
• Date Manufacturer Received: 10/24/2022
• 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