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 Appropriate Term/Code Not Available (3191)

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

Event Date 07/05/2022

Event Type  malfunction  

Manufacturer Narrative

Internal report reference number: (b)(6).Test strips were not returned for evaluation.Meter was returned for evaluation.Product testing was performed and no defect found.Returned meter did have results stored in the meter memory.Most likely underlying root cause: mlc-028: there was not enough information to determine the mlurc.Note: manufacturer contacted customer in several follow-up calls to ensure the replacement products resolved the initial concern - unable to establish contact with customer at this time.

Event Description

Consumer reported complaint that she had not used the true metrix meter but that there had already been results in the meter's memory.The customer feels well and did not report any symptoms.No medical attention associated with the use of the product was reported.The test strip lot manufacturer¿s expiration date is 10/27/2023; open vial date and product storage was not disclosed.

Manufacturer Narrative

Sections with additional information as of 25-aug-2022: h6: updated fda¿s type, findings and conclusions codes.H10: 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-028: there was not enough information to determine the mlurc.

• 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: 15153236
• MDR Text Key: 304905743
• Report Number: 1000113657-2022-00427
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00021292007928
• UDI-Public: (01)00021292007928
• 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: 08/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/27/2023
• Device Model Number: KIT, TRUE METRIX METERMG/DL
• Device Catalogue Number: RE4H01-81
• Device Lot Number: ZA4747S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2022
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 07/05/2022
• Date Manufacturer Received: 08/04/2022
• 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