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

Model Number	STRIP, TMX CVS 25CTMG/DL
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	09/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Consumer reported complaint for hi and high blood glucose test results.The customer is concerned with test results from results obtained of hi and 536 mg/dl.The customer does not know her expected blood glucose test result range.The customer reported having blurry vision; customer stated she has been having it for the past couple of days.Medical attention was not needed at the time of the call.The test strip lot manufacturer¿s expiration date is 11/30/2024 and open vial date was not disclosed.The product is not stored according to specification in the (kitchen).The customer did have another vial of test strips, same lot number, opened day of call, that had been stored and handled correctly.During the call, a blood test was performed by the customer fasting and produced test result of hi using true metrix air meter.The meter memory was reviewed for previous test result history (customer was unable to see date): result 1: hi time: 10:20 am non-fasting.Result 2: hi time: 6:23 pm fasting.Result 3: hi time: 5:28 pm unknown.Result 4: hi time 1:08 pm fasting.Result 5: 536 mg/dl time: 10:40 pm fasting.
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Meter was returned for evaluation.Product testing was performed and no defect found on returned meter.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-020: user's test strip had poor storage.Note 1: manufacturer contacted customer in a follow-up call on 11-sep-2023 to ensure the customer's condition had improved - able to establish contact with customer who stated her condition had improved and she did not currently have any diabetic symptoms.No medical intervention since the last call was reported.Customer stated that she is still using the true metrix air meter and is still obtaining hi.Note 2: manufacturer contacted customer in a follow-up call on 15-sep-2023 to ensure the replacement products resolved the initial concern - able to establish contact with customer who stated replacement products resolved initial concern.

• Brand Name: TRUE METRIX AIR
• Common Device Name: 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: 17843064
• Report Number: 1000113657-2023-00490
• Device Sequence Number: 4401886
• Product Code: NBW
• UDI-Device Identifier: 00021292007829
• UDI-Public: (01)00021292007829
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K150052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 09/29/2023

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/30/2024
• Device Model Number: STRIP, TMX CVS 25CTMG/DL
• Device Lot Number: ZB5264S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2023
• Distributor Facility Aware Date: 09/08/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/08/2023
• Initial Report FDA Received Date: 09/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown