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

Model Number KIT, TRUE METRIX METERMG/DL

Device Problem Melted (1385)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/18/2021

Event Type  malfunction  

Manufacturer Narrative

Internal report reference number: (b)(4).Lancing device was not returned for evaluation.Meter was returned for evaluation.Product testing was performed and defect found - melted meter case and broken battery door.Root cause: rc-045: battery door broken/missing due to user mechanical/stress.Note: manufacturer contacted customer in a follow-up call on 07-sep-2021 to ensure the replacement products resolved the initial concern - able to establish contact with customer who stated replacement products resolved initial concern.

Event Description

Consumer reported complaint for melted true metrix meter and lancing device.Customer stated that the test strips and lancets were not affected.The product is not stored according to specification (kitchen).The customer feels well and did not report any symptoms.No medical attention associated with the use of the product was reported.

Manufacturer Narrative

Sections with additional information as of 04-nov-2021: h6: updated fda¿s type, findings and conclusions codes.H10: returned meter was forwarded to r&d meter and qa engineer for additional evaluation.R&d investigation completed - customer's complaint was reproduced using nail polish remover (e.G.Acetone) and results were virtually identical as described by the customer.No problem found with meter design or manufacturer.Root cause was updated from root cause: rc-045: battery door broken/missing due to user mechanical/stress to root cause: rc-076: mishandled by the end user.

• Brand Name: TRUE METRIX
• Type of Device: SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER
• MDR Report Key: 12473696
• MDR Text Key: 272686844
• Report Number: 1000113657-2021-00550
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00021292007928
• UDI-Public: (01)00021292007928
• 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: 11/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: KIT, TRUE METRIX METERMG/DL
• Device Catalogue Number: RE4H01-81
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2021
• Distributor Facility Aware Date: 08/18/2021
• Date Manufacturer Received: 10/22/2021
• 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