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

Model Number	STRIP, RLN TMX 50CTMG/DL
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	02/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Meter and test strips were returned for evaluation.No defect found on returned meter and strips.Most likely underline root cause - mlc-025 strip inserted backwards or upside-down.Note: manufacturer contacted customer in a follow-up call on 02-mar-2021 to ensure the customer's condition had improved - able to establish contact with customer who stated she was no longer experiencing symptoms.Customer stated she had contacted her doctor that day due to being unable to obtain a blood glucose test result using the true metrix air meter; customer stated the doctor had prescribed her a new meter.
Event or Problem Description
Consumer reported complaint that the true metrix air meter would power up but not go into test mode.At the time of the call the customer reported having blurry vision; medical attention was not needed at the time.The product is stored according to specification in the bedroom.The test strip lot manufacturer¿s expiration date is 05/31/2022 and open vial date is 02/26/2021.The true metrix air meter did not go into test mode during the call and the customer was unable to perform a blood test.
Additional Manufacturer Narrative
Corrected sections as of (b)(6) 2021: correction on section b1 to remove product problem selection since product was returned and evaluated.Investigation yield no defect found, therefore the product problem category does not apply.

• 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
• MDR Report Key: 11576298
• Report Number: 1000113657-2021-00210
• Device Sequence Number: 3622268
• Product Code: NBW
• UDI-Device Identifier: 00021292012236
• UDI-Public: (01)00021292012236
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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,Followup
• Report Date (Section B): 07/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/31/2022
• Device Model Number: STRIP, RLN TMX 50CTMG/DL
• Device Catalogue Number: REA4H01-01
• Device Lot Number: ZX4164S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2021
• Distributor Facility Aware Date: 02/26/2021
• Initial Date Received by Manufacturer: 02/26/2021
• Supplement Date Received by Manufacturer: 06/28/2021
• Initial Report FDA Received Date: 03/26/2021
• Supplement Report FDA Received Date: 07/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention