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 Codes	Display or Visual Feedback Problem (1184); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Product problem being submitted due to test strips being part of recall # 1052693-06/13/16-001-r strip.Meter and test strips were returned, no investigation required: test strips are expired and product is discontinued.Note: manufacturer contacted customer in several follow-up calls to ensure the customer had received the replacement products and that they are working as intended - unable to establish contact with customer at this time.
Event or Problem Description
Consumer reported complaint that the true track meter does not display the blinking blood drop.Customer stated that only "code" appears in the display; the drop symbol does not appear in the display.Customer is using the incorrect test strips for the meter; customer is using true balance test strips with the true track meter.The test strips are expired - manufacturer's expiration date is 08/26/2017 and test strips are part of recall.Customer has two vials of the same lot number of test strips.The customer feels well and did not report any symptoms.No medical attention associated with the use of the product was reported.Customer was upgraded to true metrix product line.
Additional Manufacturer Narrative
Sections with additional information as of 07-jan-2022: h10: test strip lot number is expired - unable to perform retention testing.Root cause: rc-074: manufacturing processing error.

• 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
• Manufacturer Contact: karen devincent ; 2400 nw 55th court; fort lauderdale, FL 33309
• MDR Report Key: 13003676
• Report Number: 1000113657-2021-00773
• Device Sequence Number: 4873297
• Product Code: NBW
• UDI-Device Identifier: 00021292007959
• UDI-Public: (01)00021292007959
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Recall,Other,Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2022

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: 08/26/2017
• Device Model Number: STRIP, TB 50CT 360/CS
• Device Catalogue Number: H4H01-81
• Device Lot Number: BS4621
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2021
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 11/17/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/20/2021
• Supplement Date Received by Manufacturer: 12/20/2021
• Initial Report FDA Received Date: 12/14/2021
• Supplement Report FDA Received Date: 01/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown