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

Model Number STRIP, TRUE METRIX MEDIMEDI 50CT MG/DL

Device Problem Product Quality Problem (1506)

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

Event Date 09/26/2022

Event Type  malfunction  

Event Description

Consumer reported complaint for physical defect of test strips and error messages (e-0, e-4, e-5 and e-6).Customer stated that some of the test strips do not have the center strip where blood draws up.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 01/18/2024.Product storage and open vial date were not disclosed.Customer stated she did not have anymore test strips from this vial.Customer reported same complaint for different lot number of test strips: zy4319s (internal report reference: (b)(4)).

Manufacturer Narrative

Internal report reference number: (b)(4).Test strips were not returned for evaluation - customer returned an empty test strip vial.Meter was returned for evaluation.Product testing was performed and no defect found.Complaint was forwarded to production operations and internal evaluation completed.No abnormalities observed.Most likely underlying root cause: mlc-009: use error caused or contributed to event.Note: manufacturer contacted customer in a follow-up call on 20-oct-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 18-nov-2022: h6: updated fda's type of investigation, investigation findings, and investigation conclusions.H10: retention testing was performed using test strips from the same lot.Retention strips tested within specifications.

• 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: 15666183
• MDR Text Key: 303239867
• Report Number: 1000113657-2022-00567
• 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: 11/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/18/2024
• Device Model Number: STRIP, TRUE METRIX MEDIMEDI 50CT MG/DL
• Device Catalogue Number: RE4H01-81
• Device Lot Number: ZA4842S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2022
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 09/26/2022
• Initial Date Manufacturer Received: 09/26/2022
• Initial Date FDA Received: 10/25/2022
• Supplement Dates Manufacturer Received: 10/25/2022
• Supplement Dates FDA Received: 11/18/2022
• 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