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

Model Number STRIP, TMX CVS 50CT24/CASE MG/DL

Device Problems Unsealed Device Packaging (1444); Incomplete or Missing Packaging (2312)

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

Event Date 11/20/2023

Event Type  malfunction  

Manufacturer Narrative

Internal report reference number: (b)(4).Meter and test strips were not returned for evaluation.Complaint was forwarded to packaging based on complaint's description for investigations.No product was returned to thi.Internal evaluation has been completed by packaging and root cause selected.Packaging records were reviewed, no abnormalities observed.Retention testing was performed using test strips from the same lot.Retention strips tested within specifications most likely underlying root cause: mlc-009: use error caused or contributed to event.Note: manufacturer made several attempts to contact customer to ensure the customer¿s initial concern was resolved- unable to establish contact with customer.

Event Description

Consumer reported complaint for broken safety seal.The customer stated that the box appeared to be tampered with and the test strip vial lid was not open, just that the seal was broken.Customer also stated that there were only 20 test strips in the vial instead of 50.The customer feels well and did not report any symptoms.No medical intervention associated with the use of the product was reported.

• Brand Name: TRUE METRIX AIR
• 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: 18311750
• MDR Text Key: 330291457
• Report Number: 1000113657-2023-00605
• 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: K150052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: STRIP, TMX CVS 50CT24/CASE MG/DL
• Device Lot Number: ZB5328S
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 11/20/2023
• Date Manufacturer Received: 11/20/2023
• 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: Initial
• Patient Sequence Number: 1