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

Model Number STRIP, TRUE METRIX MEDIMEDI 50CT MG/DL

Device Problem Image Display Error/Artifact (1304)

Patient Problem Fall (1848)

Event Date 09/22/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Consumer reported complaint for error message (e-5).The customer feels well and did not report any symptoms.Customer stated that on the day prior to the call ((b)(6) 2022) he had been unable to check his blood glucose as he had only been able to obtain e-5.Customer stated he had taken 5 units of humalog.Customer stated he had not been able to walk and had fallen; customer stated he had been on the floor for over an hour.No further details were provided.The product is stored according to specification.The test strip lot manufacturer¿s expiration date is 02/26/2024 and open vial date was not provided.Customer had another vial of the same lot number of test strips.During the call, a blood test was performed by the customer non-fasting and produced test result of 354 mg/dl using true metrix meter; customer was satisfied with the result obtained and stated that he had just eaten 25 minutes prior.

Manufacturer Narrative

Sections with additional information as of 11-nov-2022: 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 tested within specifications.Most likely underlying root cause: mlc-062: user had poor technique.

• 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: 15615019
• MDR Text Key: 306894181
• Report Number: 1000113657-2022-00551
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 11/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/26/2024
• Device Model Number: STRIP, TRUE METRIX MEDIMEDI 50CT MG/DL
• Device Catalogue Number: RE4H01-81
• Device Lot Number: ZA4875S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 09/22/2022
• Initial Date Manufacturer Received: 09/22/2022
• Initial Date FDA Received: 10/17/2022
• Supplement Dates Manufacturer Received: 10/20/2022
• Supplement Dates FDA Received: 11/11/2022
• 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