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

Model Number KIT, TRUE METRIX METERMG/DL

Device Problem Battery Problem (2885)

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

Event Date 09/06/2022

Event Type  malfunction  

Event Description

Consumer reported complaint that the battery "exploded" in the true metrix meter.Customer stated that the battery is orange in color.The customer feels well and did not report any symptoms.No medical attention associated with the use of the product was reported.No further information was provided.

Manufacturer Narrative

Internal report reference number: (b)(4).Meter and test strips were returned - product evaluation in-process.Note: manufacturer contacted customer in a follow-up call on 19-sep-2022 to ensure the replacement products resolved the initial concern - able to establish contact with customer who stated replacement products resolved initial concern.

Manufacturer Narrative

Sections with additional information as of 20-oct-2022: h6: updated fda's type of investigation, investigation findings, and investigation conclusions.H10: meter and strips were returned for evaluation.Defect found on returned meter: unknown error- battery contacts corroded and no response upon strip insertion.Reported defect not reproduced on returned strips.Product evaluation has been completed.Internal investigation has been completed and root cause selected.Retention testing was performed using test strips from the same lot.Retention strips tested within specifications.Root cause: rc-076: mishandled by the end user.

• 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: 15494986
• MDR Text Key: 301270231
• Report Number: 1000113657-2022-00519
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00021292007
• UDI-Public: (01)00021292007
• 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: Replace
• Type of Report: Initial,Followup
• Report Date: 10/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/28/2023
• Device Model Number: KIT, TRUE METRIX METERMG/DL
• Device Catalogue Number: RE4H01-81
• Device Lot Number: ZY4646S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2022
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 09/06/2022
• Date Manufacturer Received: 09/29/2022
• 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