MAUDE Adverse Event Report: TRIVIDIA HEALTH INC TRUE2GO; SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER

Model Number	STRIP, RITE AID 25CT TT24/CS
Medical Device Problem Code	Image Display Error/Artifact (1304)
Health Effect - Clinical Code	Dry Mouth (4485)
Date of Event	09/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Adverse event report is being submitted due to symptoms related to diabetes: dry mouth.Meter and test strips were not returned for evaluation.Note: manufacturer contacted customer in several follow-up calls to ensure the customer's condition had improved and that the replacement products resolved the initial concern - unable to establish contact with customer at this time.
Event or Problem Description
Consumer reported complaint for error message.During the call, a blood test was not performed by the customer.Customer has discontinued product - customer has true2go meter.Customer was also using truetrack test strips with the true2go meter.The test strip lot manufacturer¿s expiration date is 03/31/2022 and open vial date is 09/16/2021.Product storage location was not disclosed.The customer stated she had not been testing her blood glucose for a long period of time.At the time of the call, the customer reported experiencing dry mouth; medical attention was not needed at the time.Customer was upgraded to true metrix go product line.
Additional Manufacturer Narrative
Sections with additional information as of 03-dec-2021: h6: updated fda's type of investigation, investigation findings, and investigation conclusions.H10: meter and 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-101: user used the wrong strip.

• Brand Name: TRUE2GO
• 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: 12614588
• Report Number: 1000113657-2021-00642
• Device Sequence Number: 1321017
• Product Code: NBW
• UDI-Device Identifier: 00021292008888
• UDI-Public: (01)00021292008888
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K080710
• 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,Followup
• Report Date (Section B): 12/03/2021

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/31/2022
• Device Model Number: STRIP, RITE AID 25CT TT24/CS
• Device Catalogue Number: F4H01-81
• Device Lot Number: RW5383S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 09/16/2021
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/16/2021
• Supplement Date Received by Manufacturer: 11/11/2021
• Initial Report FDA Received Date: 10/12/2021
• Supplement Report FDA Received Date: 12/03/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown