MAUDE Adverse Event Report: TRIVIDIA HEALTH, INC. TRUE METRIX GLUCOSE TEST STRIP; GLUCOSE DEHYDROGENASE, GLUCOSE

Model Number 56151146003

Device Problems Defective Device (2588); Device Displays Incorrect Message (2591)

Patient Problem Insufficient Information (4580)

Event Date 10/20/2021

Event Type  malfunction  

Event Description

True metrix glucose test strip (ndc 56151-1460-03) #25 count box.Faulty test strips.Multiple test strips generate 'e3' error code, forcing patient to retest.She will run out of strips.[lot # my4446s; exp 02/15/2023].Fda safety report id # (b)(4).

• Brand Name: TRUE METRIX GLUCOSE TEST STRIP
• Type of Device: GLUCOSE DEHYDROGENASE, GLUCOSE
• Manufacturer (Section D): TRIVIDIA HEALTH, INC.
• MDR Report Key: 12689131
• MDR Text Key: 278546264
• Report Number: MW5104903
• Device Sequence Number: 1
• Product Code: LFR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 10/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/15/2023
• Device Model Number: 56151146003
• Device Lot Number: MY4446S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Weight: 52