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 Hyperglycemia (1905)

Event Date 12/02/2021

Event Type  malfunction  

Manufacturer Narrative

Internal report reference number: (b)(4).Test strips were not returned for evaluation.Meter was returned - reported defect not reproduced.No defect found most likely underlying root cause: (b)(4): user had an inaccurate reference: self: the person is using themselves as the reference or how they feel at the time they run the blood test.Note: manufacturer contacted customer in a follow-up call 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 and erratic blood glucose test results.The customer is concerned with test results from results obtained of 143, 191, 320, 313 and 333mg/dl.The customer¿s expected fasting blood glucose test result range is 120-140mg/dl.The customer feels well and did not report any symptoms.Medical attention is not reported as a result of the actual blood glucose results.During the call, a back to back blood test was performed by the customer non-fasting and produced test results of 291 mg/dl and 242mg/dl using true metrix meter; customer was not satisfied with the results obtained.The product is stored according to specification in the bedroom.The test strip lot manufacturer¿s expiration date is 08/19/2022 and open vial date is 11/2021.The meter memory was reviewed for previous test result history (date/time not set): result 1 : 143 mg/dl date: (b)(6) 2021 time: 5:00 pm fasting, result 2 : 191 mg/dl date: (b)(6) 2021 time: 4:59 pm fasting, result 3 : 320 mg/dl date: (b)(6) 2021 time: 8:15 pm fasting, result 4 : 313 mg/dl date: (b)(6) 2021 time: 8:13 am fasting, result 5 : 333 mg/dl date: (b)(6) 2021 time: 8:13 am fasting.

• 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: 13119244
• MDR Text Key: 291243339
• Report Number: 1000113657-2021-00812
• 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
• Report Date: 12/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/19/2022
• Device Model Number: STRIP, SUNMARK TMX 50CTMG/DL MM
• Device Catalogue Number: RE4H01-81
• Device Lot Number: ZX4267S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2021
• Distributor Facility Aware Date: 12/02/2021
• Date Manufacturer Received: 12/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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