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

Model Number	METER, PRO MCKESSON TMXMG/DL
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Blurred Vision (2137); Swelling/ Edema (4577)
Date of Event	10/25/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Consumer reported complaint that the meter was not working with the test strips.Customer is using true metrix pro meter which is intended for multi-patient use.Customer was also using another brand of strips with the meter.At the time of the call the customer reported symptoms of blurry vision and leg swelling.Medical attention was not needed at the time.True metrix product line replacements were sent to customer.
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Adverse event report is being submitted due to symptoms related to diabetes: blurry vision and leg swelling.Meter and test strips were not returned for evaluation.Most likely underlying root cause: using incorrect test strip.Note 1: manufacturer contacted customer in a follow-up call on (b)(6) 2022 to ensure the customer's condition had improved - able to establish contact with customer who stated she was still experiencing the symptoms; customer stated she has been having the symptoms for a few weeks.Customer stated she has a scheduled appointment with a cardiologist the following day.Note 2: 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.

• Brand Name: TRUE METRIX PRO
• 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: 15824627
• Report Number: 1000113657-2022-00604
• Device Sequence Number: 6156812
• Product Code: NBW
• UDI-Device Identifier: 10612479210254
• UDI-Public: (01)10612479210254
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K140100
• 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
• Report Date (Section B): 11/18/2022

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 Model Number: METER, PRO MCKESSON TMXMG/DL
• Device Catalogue Number: RE4H01P-43
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 10/25/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/25/2022
• Initial Report FDA Received Date: 11/18/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown