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

Model Number STRIP, SUNMARK TMX 50CTMG/DL

Device Problem High Test Results (2457)

Patient Problem Sweating (2444)

Event Date 01/25/2021

Event Type  Injury  

Manufacturer Narrative

Internal report reference number: (b)(4).Meter and test strips were returned for evaluation.Product testing was performed and no defect found.Most likely underlying root cause: mlc-020: user's test strip had poor storage.Note: manufacturer contacted customer in a follow-up call on 08-feb-2021 to ensure the replacement products resolved the initial concern - able to establish contact with customer and stated replacement product resolved initial concern.Customer reported that she contacted her doctor (b)(6) 2021 due to the low blood glucose test results obtained and that the doctor had recommended a change to customer's diabetic medication.

Event Description

Consumer reported complaint for high and low blood glucose test results.The customer is concerned with test results from results obtained of 111, 83, 70, 62, 148, 200 and 303 mg/dl; customer stated the 200 and 303 mg/dl were am fasting results.The customers expected am fasting blood glucose test result is 93 mg/dl.The customer feels well and did not report any symptoms.Customer stated she had felt sweaty at the time the result of 62mg/dl had been obtained.Medical attention is not reported as a result of the actual blood glucose results and reported symptoms.During the call, a back to back blood test was not performed by the customer.The product is not stored according to specification and is stored in the kitchen.The test strip lot manufacturers expiration date is 04/14/2022 and open vial date is undisclosed.The customer did not have another vial of test strips that had been stored and handled correctly.The meter memory was reviewed for previous test result history: (b)(6).

Manufacturer Narrative

Corrected sections as of 09-jul-2021: correction on section b1 to remove product problem selection since product was returned and evaluated.Investigation yield no defect found, therefore the product problem category does not apply.

• 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
• MDR Report Key: 11337348
• MDR Text Key: 232182218
• Report Number: 1000113657-2021-00119
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• PMA/PMN Number: K140100
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 07/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/14/2022
• Device Model Number: STRIP, SUNMARK TMX 50CTMG/DL
• Device Catalogue Number: RE4H01-81
• Device Lot Number: ZX4113S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2021
• Distributor Facility Aware Date: 01/25/2021
• Date Manufacturer Received: 06/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention