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

Model Number STRIP, TRUE METRIX 100CTMG/DL

Device Problem High Test Results (2457)

Patient Problem Presyncope (4410)

Event Date 08/31/2022

Event Type  malfunction  

Manufacturer Narrative

Internal report reference number: (b)(4).Test strips were not returned for evaluation.Meter was returned - reported defect not reproduced on returned meter.Product evaluation has been completed, and most likely underlying root cause selected.Most likely underlying root cause: mlc-018: user has high glucose value note: manufacturer contacted customer in a follow-up call on 06-sep-2022 to ensure the customer's condition had improved and that the replacement products resolved the initial concern - able to establish contact with customer who stated he was not currently having any diabetic symptoms and the replacement products resolved initial concern.No medical intervention since the last call was reported.

Event Description

Consumer reported complaint for high blood glucose test results.The customer is concerned with test results from results obtained of 362, 371, 324 and 333 mg/dl.The customer¿s expected am fasting blood glucose test result is 140 mg/dl.At the time of the call the customer reported feeling lightheaded; medical attention was not need at the time.During the call, a blood test was performed by the customer fasting and produced test result of 471 mg/dl using true metrix air meter.The product is stored according to specification in the dining room.The test strip lot manufacturer¿s expiration date is 12/24/2023 and open vial date is one week ago.The meter memory was reviewed for previous test result history: result 1: 362 mg/dl date: (b)(6) 2022 time: 12:23 am fasting.Result 2: 371 mg/dl date: (b)(6) 2022 time: 12:23 am fasting.Result 3: 324 mg/dl date: (b)(6) 2022 time: 10:13 am fasting.Result 4: 333 mg/dl date: (b)(6) 2022 time: 8:59 am fasting result 5: 336 mg/dl date: (b)(6) 2022 time: 11:30 am 2 hrs.After meal.

Manufacturer Narrative

Sections with additional information as of 18-oct-2022: h6: updated fda¿s type, findings and conclusions codes.H10: 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: (b)(6): user has high glucose value.

• 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: 15484623
• MDR Text Key: 301021792
• Report Number: 1000113657-2022-00512
• 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,Followup
• Report Date: 10/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/24/2023
• Device Model Number: STRIP, TRUE METRIX 100CTMG/DL
• Device Catalogue Number: REA4H01-01
• Device Lot Number: ZA4818S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2022
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 08/31/2022
• Date Manufacturer Received: 09/26/2022
• 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