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	High Test Results (2457)
Health Effect - Clinical Codes	Fatigue (1849); Dizziness (2194); Urinary Frequency / Polyuria (2275)
Date of Event	09/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Meter and test strips were not returned for investigation.Most likely underlying root cause: mlc-18: user has high glucose value.Meter udi: (b)(4).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.Urgent customer care letter was sent to contact customer care.Note: manufacturer contacted customer in a follow-up call to ensure the replacement products resolved the initial concern - unable to establish contact with customer at this time.Product notification letter sent to contact customer care.
Event or Problem Description
Consumer reported complaint for high blood glucose test results.The customer is concerned with tests results obtained of over 270mg/dl.The expected fasting blood glucose test result range is under 270mg/dl.The customer did report diabetic symptoms of cotton mouth, dizziness, fatigue and increased urination.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 performed by the customer and produced test results of 565mg/dl and 553mg/dl fasting using meter.The test strip lot manufacturer¿s expiration date is 03/26/2020 and open vial date is 9/5/2019.The meter memory was reviewed for previous test result history.(b)(6).

• 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: 9134792
• Report Number: 1000113657-2019-10018
• Device Sequence Number: 1825692
• Product Code: NBW
• UDI-Device Identifier: 00021292008888
• UDI-Public: (01)00021292008888
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Replace,Other
• Type of Report: Initial
• Report Date (Section B): 09/30/2019

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: 03/26/2020
• Device Model Number: STRIP, CVS 25CT TT
• Device Catalogue Number: A4H01-81
• Device Lot Number: RV5167
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 09/05/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/05/2019
• Initial Report FDA Received Date: 09/30/2019
• Patient Sequence Number: 1