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

Model Number STRIP, TRUE METRIX 100CTMG/DL

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Code Available (3191)

Event Date 11/16/2020

Event Type  malfunction  

Manufacturer Narrative

Internal report reference number: (b)(4).Meter and test strips were not returned for evaluation.Note: manufacturer contacted customer in several follow-up calls to ensure the patient condition improved and initial concern is resolved - unable to establish contact with customer at this time.

Event Description

Consumer reported complaint for error messages (e-3) accompanied by symptoms.Home health nurse is calling on behalf of the customer.The expected fasting blood glucose test result range was undisclosed.The customer did report symptom of feeling hungry.Medical attention is not reported as a result of the actual blood glucose results.The product is stored according to specification in the living room.The customer was using the incorrect testing technique, nurse states she was applying blood to the strip first before inserting the strip into the meter.During the call a blood test was performed by the customer and produced test results of 259mg/dl non-fasting using meter.Nurse does not know if accurate since its a new patient.The test strip lot manufacturer¿s expiration date is 04/30/2022 and open vial date is 11/15/2020.The meter memory was not reviewed for previous test result history.

Manufacturer Narrative

Sections with additional information as of 19-jan-2021: 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.Mlc-030: user applied blood to strip before inserting strip into meter.Correction: d1: brand name from "true metrix" to "true metrix air.".

• Brand Name: TRUE METRIX AIR
• 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: 10996341
• MDR Text Key: 229565569
• Report Number: 1000113657-2020-00891
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• PMA/PMN Number: K150052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2022
• Device Model Number: STRIP, TRUE METRIX 100CTMG/DL
• Device Catalogue Number: REA4H01-01
• Device Lot Number: ZX4120S
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 11/16/2020
• Date Manufacturer Received: 12/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1