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

Model Number	STRIP, RITE AID 25CT TT24/CS
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Meter and test strips were not returned for evaluation.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.Complaint was reported outside of the us.Note: manufacturer contacted customer in a follow-up call to ensure the customer's products resolved the initial concern : able to establish contact with customer and stated that she will be obtaining an ¿american¿ meter to go with her ¿american¿ strips as it is too difficult for her to get the strips.Customer states that she will do the conversion.Customer was previously advised that mg/dl is use for in the us and that she should be using mmol strips with the meter.
Event or Problem Description
Consumer reported complaint for high and erratic blood glucose readings and strips reading in mmol but labeled for mg/dl.Customer advised that her brother purchases the strips from the us and then brings them to her in canada and that he has been doing that for more than a year.The customer is concerned with all test results obtained.Customer was advised that canada uses the mmol unit of measure and that the us uses mg/dl.Advised customer that she should be purchasing her strips in canada due to the unit of measure as she wants to make sure that she is getting accurate results.Customer understands and advised that it is a cost issue for her.The expected fasting blood glucose test result range is 9.0mmol/l.The customer did not report symptoms.Medical attention is not reported as a result of the actual blood glucose results.The product is stored according to specification in the bedroom.During the call a back to back blood test was not performed by the customer.The test strip lot manufacturer¿s expiration date is 03/18/2022 and open vial date is three weeks ago.The meter memory was reviewed for previous test result history.(b)(6).
Additional Manufacturer Narrative
Sections with additional information as of (b)(6) 2020: h6: updated fda's method, result, and conclusion codes h10: meter was not returned for evaluation.Test strips were not returned for evaluation.Retention testing was performed using test strips from the same lot.Retention strip lot tested and passed.

• Brand Name: TRUETRACK
• 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: 10323705
• Report Number: 1000113657-2020-00516
• Device Sequence Number: 515746
• Product Code: NBW
• UDI-Device Identifier: 00021292008888
• UDI-Public: (01)00021292008888
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K032657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2020

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: 03/18/2022
• Device Model Number: STRIP, RITE AID 25CT TT24/CS
• Device Catalogue Number: A4H01-81
• Device Lot Number: RW5374S
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 06/25/2020
• Initial Date Received by Manufacturer: 06/25/2020
• Supplement Date Received by Manufacturer: 08/20/2020
• Initial Report FDA Received Date: 07/24/2020
• Supplement Report FDA Received Date: 09/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1