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

Model Number STRIP, TRUE METRIX 50CTMG/DL

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/05/2019

Event Type  malfunction  

Manufacturer Narrative

Internal report reference number: (b)(4).Meter and test strips were not returned for evaluation.Most likely underlying root cause: mlc-20: user's test strip had poor storage note: manufacturer contacted customer in a follow-up call to ensure the replacement products resolved the initial concern - able to establish contact with customer and stated replacement product resolved initial concern.

Event Description

Consumer reported complaint for high blood glucose test results.The customer is concerned with all results over 200 mg/dl fasting in the morning.Customer also stated results from the meter were higher than those obtained with another device; actual meter to meter comparison results were not provided.The customers expected fasting blood glucose test result range is 130-150 mg/dl.Customer was not using proper testing techniques.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 not performed by the customer.The product is not stored according to specification and it is stored in the kitchen.The test strip lot manufacturers expiration date is 04/23/2021.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

Sections with additional information as of 20-feb-2020: h6: updated fda's method, result, and conclusion 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 tested and passed.

• 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: 9532287
• MDR Text Key: 219577759
• Report Number: 1000113657-2019-10264
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00021292007836
• UDI-Public: (01)00021292007836
• 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: 02/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/23/2021
• Device Model Number: STRIP, TRUE METRIX 50CTMG/DL
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MW3552S
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 12/05/2019
• Date Manufacturer Received: 01/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1