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	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2022
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.No product complaint was alleged by the customer.Meter and test strips were not returned to manufacturer.Manufacturer contacted customer in a follow-up call on 27-may-2022 to ensure the customer¿s initial concern was resolved - able to establish contact with customer who stated the replacement products resolved initial concern.
Event or Problem Description
Consumer called to inquire about returning discontinued product; customer has true balance test strips.Customer had never used the test strips; customer does not have a true balance meter.The test strips are expired - manufacturer's expiration date is 08/26/2017 and test strips are part of recall.Customer did not report a complaint associated with the products.The customer feels well and did not report any symptoms.No medical attention associated with the use of the products was reported.Customer already had a true metrix meter and was sent a true metrix vial of test strips.
Additional Manufacturer Narrative
Sections with additional information as of 11-jul-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: 14626191
• Report Number: 1000113657-2022-00322
• Device Sequence Number: 4843492
• 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: Other,Recall,Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2022

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?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 05/12/2022
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/12/2022
• Supplement Date Received by Manufacturer: 06/13/2022
• Initial Report FDA Received Date: 06/07/2022
• Supplement Report FDA Received Date: 07/11/2022
• 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