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

Model Number STRIP, TMX AID 100CT12/CASE MG/DL

Device Problem Material Discolored (1170)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/22/2020

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-28: there was not enough information to determine the mlurc.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.Product notification letter sent to contact customer care.

Event Description

Consumer reported complaint for risk associated with contaminated test strips.The expected fasting blood glucose test result range is undisclosed.The customer did not report symptoms.Medical attention is not reported as a result.The product storage location is undisclosed.The test strip lot manufacturer¿s expiration date is (b)(6) 2020 and open vial date is undisclosed.The meter memory was not reviewed for previous test result history.

Manufacturer Narrative

Sections with additional information as of 15-jul-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.Corrected sections as of 15-jul-2020: h10: most likely underlying root cause corrected from "mlc-28: there was not enough information to determine the mlurc" to "mlc-9: user error caused or contributed to event".

• 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: 10071692
• MDR Text Key: 228489668
• Report Number: 1000113657-2020-00316
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00021292007836
• UDI-Public: (01)00021292007836
• 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: Replace
• Type of Report: Initial,Followup
• Report Date: 07/15/2020

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: 12/27/2020
• Device Model Number: STRIP, TMX AID 100CT12/CASE MG/DL
• Device Catalogue Number: REA4H01-01
• Device Lot Number: MW3383S
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/22/2020
• Initial Date Manufacturer Received: 04/22/2020
• Initial Date FDA Received: 05/19/2020
• Supplement Dates Manufacturer Received: 06/17/2020
• Supplement Dates FDA Received: 07/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1