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

Model Number	METER, AIR TVH TMX NFRSMG/DL
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial report reference number: (b)(4).Meter was returned for evaluation; no defect was detected.Test strips were returned for evaluation; no defect was detected.Most likely underlying root cause: mlc-58: user had an inaccurate reference: self: the person is using themselves as the reference or how they feel at the time they run the blood test.Note: manufacturer contacted customer in a follow-up call on 01-jul-2020 to ensure the replacement products resolved the initial concern - able to establish contact with customer and stated he went to the doctor last week because he did not trust the results.The doctor checked the customer's blood glucose and gave a result of 130 mg/dl undisclosed if fasting or non fasting.
Event or Problem Description
Consumer reported complaint for low and erratic blood glucose test results.The customer is concerned with test results from results obtained of 74 mg/dl and back to back blood tests of 144, 135, 120 and 134 mg/dl.The customer did not know what his expected glucose range should be.The customer felt well and did not report any symptoms.Medical attention was not reported as a result of the actual blood glucose results at time of initial call.During the call, a back to back blood test was performed by the customer non-fasting and produced test results of 68 mg/dl and 71 mg/dl using truemetrix air meter.The product is stored according to specification in the bedroom.The test strip lot manufacturer¿s expiration date is 10/17/2021 and open vial date is (b)(6) 2020.The meter memory was reviewed for previous test result history: (b)(6).

• 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: 10337667
• Report Number: 1000113657-2020-00530
• Device Sequence Number: 19577839
• Product Code: NBW
• UDI-Device Identifier: 00021292007447
• UDI-Public: (01)00021292007447
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 07/29/2020

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/17/2021
• Device Model Number: METER, AIR TVH TMX NFRSMG/DL
• Device Catalogue Number: REA4H01-01
• Device Lot Number: MX4209S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2020
• Distributor Facility Aware Date: 07/01/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/01/2020
• Initial Report FDA Received Date: 07/29/2020
• 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: Other