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

Model Number	KIT, TRUEBALANCE STARTER40/CS
Medical Device Problem Codes	High Test Results (2457); Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Meter and test strips were not returned for evaluation.Manufacturer was unable to contact customer in follow-up call to ensure the replacement products resolved the initial concern - customer had declined to provide telephone number.
Event or Problem Description
Consumer initially reported complaint for error messages (e-4 and e-8).During the call, the true balance meter displayed hi when the customer inserted a test strip.The meter memory was reviewed and customer reported a result of lo.Customer stated that she does not test regularly and did not remember this result.The product is not stored according to specification (kitchen).The test strip lot manufacturer¿s expiration date is 10/22/2023 and open vial date was not disclosed.The customer did not have another vial of test strips that had been stored and handled correctly.The meter memory was reviewed for previous test result history: (b)(6).
Additional Manufacturer Narrative
Sections with additional information as of 29-jun-2022: h6: updated fda¿s type, findings and conclusions 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 within specifications.Most likely underlying root cause: mlc-020: user's test strip had poor storage.

• 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: 14398235
• Report Number: 1000113657-2022-00281
• Device Sequence Number: 5058463
• Product Code: NBW
• UDI-Device Identifier: 00021292003135
• UDI-Public: (01)00021292003135
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Other,Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2022

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: 10/22/2023
• Device Model Number: KIT, TRUEBALANCE STARTER40/CS
• Device Catalogue Number: H4H01-81
• Device Lot Number: BY5481S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 04/18/2022
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/18/2022
• Supplement Date Received by Manufacturer: 06/02/2022
• Initial Report FDA Received Date: 05/13/2022
• Supplement Report FDA Received Date: 06/29/2022
• 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