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

Model Number STRIP, CVS TMX 30CT24/CASE MG/DL

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 03/11/2024

Event Type  malfunction  

Event Description

Consumer reported complaint for erratic, high and low blood glucose test results.The customer is concerned with test results from back-to-back test results of 76, 131 and 99 mg/dl and 87 and 110 mg/dl.The customer¿s expected am fasting blood glucose test result is <100 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 01/31/2025 and open vial date is 03/03/2024.The meter memory was reviewed for previous test result history: result 1: 76 mg/dl; date: (b)(6); time: 8:04 am; fasting.Result 2: 131 mg/dl; date: (b)(6);time: 8:02 am fasting.Result 3: 99 mg/dl; date: (b)(6); time: 7:58 am fasting.Result 4: 87 mg/dl ; date: (b)(6); time: 7:21 am fasting.Result 5: 110 mg/dl; date: (b)(6); time: 7:19 am fasting.

Manufacturer Narrative

Internal complaint reference: case-(b)(4).Meter and 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-062: user had poor technique.Note: manufacturer contacted customer in a follow-up call on 01-apr-2024 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 06-may-2024: test strips were not returned for evaluation - customer returned empty test strip vial.Meter was returned for evaluation.Product testing was performed and no defect found on returned meter.Most likely underlying root cause: mlc-062: user had poor technique.

• 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
• MDR Report Key: 19043776
• MDR Text Key: 340113183
• Report Number: 1000113657-2024-00136
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00021292009120
• UDI-Public: (01)00021292009120
• 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,Followup
• Report Date: 05/06/2024

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 Model Number: STRIP, CVS TMX 30CT24/CASE MG/DL
• Device Lot Number: ZB5321S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 03/11/2024
• Initial Date Manufacturer Received: 03/11/2024
• Initial Date FDA Received: 04/04/2024
• Supplement Dates Manufacturer Received: 04/10/2024
• Supplement Dates FDA Received: 05/06/2024
• 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