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

Model Number KIT, GO CVS TMX METERMG/DL

Device Problem Product Quality Problem (1506)

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

Event Date 08/26/2022

Event Type  malfunction  

Manufacturer Narrative

Internal report reference number: (b)(4).Meter and test strips were not returned for evaluation.Manufacturer contacted customer in a follow-up call on (b)(6) 2022 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 the true metrix test strips did not fit into the port of the true metrix go meter.The customer feels well and did not report any symptoms.No medical attention associated with the use of the products was reported.Customer stated that the test strips are being stored in her purse.During the call the customer attempted to insert the test strips; the test strips would not fit inside the test port of the meter.Customer stated that she had another meter; customer was able to insert the test strips into her other device.

Manufacturer Narrative

Sections with additional information as of 12-oct-2022: h10: meter was not returned for evaluation.Test strips were not returned for evaluation.Retention testing was performed using test strips from the same lot.Retention strip lot passed within specifications.Most likely underlying root cause: mlc-028: there was not enough information to determine the mlurc.

Manufacturer Narrative

Sections with additional information as of 03-jan-2023: d9: device available for evaluation.H3: device evaluated by manufacturer.H6: updated fda¿s type, findings and conclusions codes.H10: test strips were not returned for evaluation.Meter was returned for evaluation.Product testing was performed and no defect found.Most likely underlying root cause updated from "mlc-028: there was not enough information to determine the mlurc" to mlc-073: user not familiar with system ifu.

• Brand Name: TRUE METRIX GO
• 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: 15455793
• MDR Text Key: 306258092
• Report Number: 1000113657-2022-00508
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00021292007706
• UDI-Public: (01)00021292007706
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143548
• 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,Followup
• Report Date: 01/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2023
• Device Model Number: KIT, GO CVS TMX METERMG/DL
• Device Catalogue Number: RF4H01-01
• Device Lot Number: ZA4828S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 08/26/2022
• Date Manufacturer Received: 12/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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