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

Model Number	KIT, TRUEBALANCE STARTER40/CS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/26/2020
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-12: product expired.Note: manufacturer contacted customer in a follow-up call on 30-mar-2020 to ensure that the customer's condition improved - able to establish contact with customer and stated she called her doctor to consult about her condition.Doctor told customer she will be taken off januvia and will reduce her remaining diabetic medication.Customer spoke with cms and they will send her another brand meter since they no longer have truebalance.Note: adverse event report is being submitted due to customer contacting doctor related to diabetes.
Event or Problem Description
Consumer reported complaint for using expired strips leading to contacting doctor.The expected fasting blood glucose test result range is undisclosed.The customer did not report symptoms at time of call.Medical attention is reported as a result.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 05/13/2018 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: 9977264
• Report Number: 1000113657-2020-00248
• Device Sequence Number: 3296274
• Product Code: NBW
• UDI-Device Identifier: 00021292003135
• UDI-Public: (01)00021292003135
• Combination Product (Y/N): N
• 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
• Type of Report: Initial
• Report Date (Section B): 04/20/2020

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: 05/13/2018
• Device Model Number: KIT, TRUEBALANCE STARTER40/CS
• Device Catalogue Number: H4H01-81
• Device Lot Number: BS4831
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/26/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/26/2020
• Initial Report FDA Received Date: 04/20/2020
• 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: Required Intervention