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

Model Number STRIP, SUNMARK TMX 100CTMG/DL

Device Problem Product Quality Problem (1506)

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

Event Date 09/14/2022

Event Type  malfunction  

Event Description

Consumer reported complaint for physical defect of test strips.Customer stated that the true metrix test strips were not fitting correctly into the true metrix meter.Customer stated that when she inserts the strip into the meter, the meter does come on however the strip is "not hitting the back of the internal meter correctly and feels that they are not cut correctly." customer advised that there was no damage to the product packaging when it was purchased and seal was intact.The test strip lot manufacturer¿s expiration date is 07/28/2023; product storage and open vial date were not disclosed.The customer feels well and did not report any symptoms.No medical attention associated with the use of the products was reported.

Manufacturer Narrative

(b)(4).Test strips were not returned for evaluation - customer had returned an empty test strip vial.Note: manufacturer contacted customer in a follow-up call on 27-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 03-nov-2022: h6: updated fda¿s type, findings and conclusions codes.H10: test strips were not returned for evaluation - customer had returned an empty test strip vial, unable to test.Retention testing was performed using test strips from the same lot.Retention strip lot passed within specifications.Complaint was forwarded to production operations and internal evaluation was completed.No abnormalities observed.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: 15580629
• MDR Text Key: 307036856
• Report Number: 1000113657-2022-00534
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00021292007836
• UDI-Public: (01)00021292007836
• 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: 11/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2022
• 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: STRIP, SUNMARK TMX 100CTMG/DL
• Device Catalogue Number: RE4H01-81
• Device Lot Number: ZY4646S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 09/14/2022
• Date Manufacturer Received: 10/11/2022
• 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