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

Model Number KIT, WALGREENS TMX METERMG/DL #348013

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 06/27/2023

Event Type  malfunction  

Event Description

Consumer reported complaint for previously used product.Walgreens pharmacy manager is calling on behalf of the customer.Pharmacy manager stated that a customer called them and advised that when she had opened the box of the meter kit purchased from them, there was a used alcohol prep pad in the box and the lancing device had blood on it.Pharmacy manager did not disclose if customer advised that the test strips were used.Test strip lot information was not provided.The customer did not report symptoms and no medical attention was reported.Pharmacy was not able to provide any additional information as she stated that she is awaiting the customer to return the products back to the pharmacy and that pharmacy will provide a refund.

Manufacturer Narrative

Internal report reference number: (b)(6).Meter and test strips were not returned for evaluation.Most likely underlying root cause: mlc-028: there was not enough information to determine the mlurc.Note: manufacturer contacted pharmacy in a follow-up call on 11-jul-2023 to ensure that the initial concern was resolved - able to establish contact with pharmacy who stated the initial issue has been resolved.

Manufacturer Narrative

Sections with additional information as of 29-aug-2023: h6: updated fda¿s type, findings and conclusions codes.H10: meter and test strips were not returned for evaluation.Complaint was forwarded to packaging and internal evaluation was completed.No abnormalities observed.

• 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: 17379665
• MDR Text Key: 319604207
• Report Number: 1000113657-2023-00389
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00021292007690
• UDI-Public: (01)00021292007690
• 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,Distributor
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: KIT, WALGREENS TMX METERMG/DL #348013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 06/27/2023
• Date Manufacturer Received: 08/17/2023
• 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: A
• Patient Sequence Number: 1