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

Model Number	STRIP, TB 50CT 360/CS
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Codes	Dizziness (2194); Polydipsia (2604)
Date of Event	06/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Meter was returned for evaluation; no defect was detected.Most likely underlying root cause: mlc-12: product expired.Note: manufacturer contacted customer in a follow-up call on 01-jul-2020 to ensure that the customer's condition improved - able to establish contact with customer and stated no longer experiencing symptoms and no medical attention was required.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 replacement product resolved initial concern.
Event or Problem Description
Consumer reported complaint for hi display.The expected fasting blood glucose test result range is 240-490mg/dl.The customer did report symptoms of feeling shaky, dizzy and thirsty.Medical attention is not reported as a result of the actual blood glucose results.The product storage location is undisclosed.During the call, a back to back blood test was not performed by the customer.The test strip lot manufacturer¿s expiration date is 07/18/2018 (expired) and open vial date is undisclosed.The meter memory was not reviewed for previous test result history.

• Brand Name: TRUEBALANCE
• 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: 10323566
• Report Number: 1000113657-2020-00514
• Device Sequence Number: 515744
• Product Code: NBW
• UDI-Device Identifier: 00021292007959
• UDI-Public: (01)00021292007959
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K090495
• 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): 07/24/2020

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: 07/18/2018
• Device Model Number: STRIP, TB 50CT 360/CS
• Device Catalogue Number: H4H01-81
• Device Lot Number: BU4860
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2020
• Distributor Facility Aware Date: 06/29/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/29/2020
• Initial Report FDA Received Date: 07/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1