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

Model Number STRIP, TRUE METRIX NFRS24/CS 50CT MG/DL

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457)

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

Event Date 02/27/2024

Event Type  malfunction  

Event Description

Consumer reported complaint for high and erratic blood glucose test results.The customer is concerned with test results from back to back blood tests of 372 and 176 mg/dl am fasting.The customer¿s expected am fasting blood glucose test result range is 159-167 mg/dl.The customer feels well and did not report any symptoms.Medical attention is not reported as a result of the actual blood glucose results.During the call, a back to back blood test was not performed by the customer.The product is stored according to specification in the bedroom.The test strip lot manufacturer¿s expiration date is 03/25/2022 (expired).The customer did not have another vial of test strips that had been stored and handled correctly.The meter memory was not reviewed for previous test result history.

Manufacturer Narrative

Internal report reference number: (b)(4).Expired test strips were not returned for evaluation.Meter was returned.Reported defect not reproduced on returned meter.Most likely underlying root cause: mlc-012: product expired note: manufacturer made several attempts to contact customer to ensure the replacement products resolved the initial concern - unable to establish contact with customer.

• 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: 18961110
• MDR Text Key: 338486508
• Report Number: 1000113657-2024-00122
• 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: Replace
• Type of Report: Initial
• Report Date: 03/22/2024

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: 03/25/2022
• Device Model Number: STRIP, TRUE METRIX NFRS24/CS 50CT MG/DL
• Device Lot Number: ZX4055S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2024
• Distributor Facility Aware Date: 02/27/2024
• Initial Date Manufacturer Received: 02/27/2024
• Initial Date FDA Received: 03/22/2024
• 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