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 High Test Results (2457)

Patient Problem Muscle Weakness (1967)

Event Date 11/29/2022

Event Type  malfunction  

Manufacturer Narrative

Internal report reference number: (b)(4).Meter and test strips were not returned for evaluation.Note 1: manufacturer contacted customer in a follow-up call on 30-nov-2022 to ensure the customer's condition had improved- able to establish contact with customer who stated her condition had improved and she did not currently have any diabetic symptoms.No medical intervention since the last call was reported.Note 2: 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 high blood glucose test results.The customer is concerned with test results from meter to meter comparison of 150 mg/dl using true metrix meter and 78 mg/dl using another device; tests were performed 2 hours post meal.The customer does not know their expected blood glucose test result range; customer advised that her diabetes is currently uncontrolled.At the time of the call the customer reported feeling weak; medical attention was not needed at the time.During the call, meter to meter comparison blood tests were performed by the customer non-fasting and produced test results of 122 mg/dl using true metrix meter and 80 mg/dl using another device.The product is stored according to specification in the living room.The test strip lot manufacturer¿s expiration date is 09/30/2023 and open vial date is 2 days prior to call.The meter memory was not reviewed for previous test result history.

Manufacturer Narrative

Sections with additional information as of 11-jan-2023: h6: updated fda¿s type, findings and conclusions codes.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 strip lot passed within specifications.Most likely underlying root cause: mlc-055: user had an inaccurate reference: competitor¿s meter: the end user is comparing results obtained from trividia¿s bgm system to the results from a competitor¿s bgm system.

• 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: 15988065
• MDR Text Key: 308489572
• Report Number: 1000113657-2022-00659
• 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
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 01/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2022
• Is this an Adverse Event Report?: No
• 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: ZA4721S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 11/29/2022
• Date Manufacturer Received: 12/19/2022
• 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