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

Model Number	STRIP, CVS 25CT TT
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	Fatigue (1849)
Date of Event	02/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Meter and test strips were not returned for evaluation, most likely underlying root cause: mlc-62: user had poor technique.Note: manufacturer contacted customer in a follow-up call to ensure that the customer's condition improved - unable to establish contact with customer at this time.No product notification letter sent since no customer address on file.
Event or Problem Description
Consumer reported complaint for e-3 error code.The product is stored according to specification in the bedroom.The test strip lot manufacturer¿s expiration date is 09/30/2021 and open vial date is (b)(6) 2020.During the call, a blood test was performed by the customer fasting and produced test result of 380 mg/dl using truetrack meter.Customer was satisfied with the blood glucose test result obtained, stating she believed it to be accurate as she was feeling drowsy at time of call in relation to her diabetes.Medical attention was not needed at the time of the call.
Additional Manufacturer Narrative
Sections with additional information as of 22-apr-2020: b2: adverse event report is being submitted due to symptoms related to diabetes - drowsy.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.Corrected sections as of 22-apr-2020: h1: type of reportable event corrected from "malfunction" to "serious injury".H10: most likely underlying root cause corrected from "mlc-62: user had poor technique" to "mlc-30: user applied blood to strip before inserting strip into meter".

• 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: 9872185
• Report Number: 1000113657-2020-00184
• Device Sequence Number: 3040606
• Product Code: NBW
• UDI-Device Identifier: 00021292008888
• UDI-Public: (01)00021292008888
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 04/22/2020

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: 09/30/2021
• Device Model Number: STRIP, CVS 25CT TT
• Device Catalogue Number: A4H01-81
• Device Lot Number: RW5344S
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/28/2020
• Initial Date Received by Manufacturer: 02/28/2020
• Supplement Date Received by Manufacturer: 04/09/2020
• Initial Report FDA Received Date: 03/24/2020
• Supplement Report FDA Received Date: 04/22/2020
• 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