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

Model Number STRIP, TRUE METRIX 50CTMG/DL

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 04/12/2023

Event Type  Injury  

Event Description

Consumer reported complaint for true metrix meter, customer stated when he attempted to test he saw flashing strip with flashing blood drop and thought it was the battery.Customer had discarded the product and was unable to provide serial and lot information.Customer states that he had the meter for years and stopped testing himself 6 months ago.The customer feels well and did not report any symptoms.Customer stated that he had an episode last week and he now has to start testing himself again.Customer stated he had purchased a new meter, but the new meter is also doing the same thing, showing the strips and flashing blood drop (internal report reference (b)(4)).No information was provided regarding the episode he had experienced last week.Customer did not advise when he went to the hospital, but that he got out of the hospital on (b)(6)2023.

Manufacturer Narrative

Internal report reference number: (b)(4).Meter and test strips were not returned for evaluation.Most likely underlying root cause: mlc-062: user had poor technique.Note: manufacturer contacted customer in several follow-up calls to ensure the initial concern is resolved - unable to establish contact with customer at this time.

• Brand Name: TRUE METRIX
• Type of Device: 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: 16887587
• MDR Text Key: 314753712
• Report Number: 1000113657-2023-00255
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140100
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 05/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: STRIP, TRUE METRIX 50CTMG/DL
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/12/2023
• Date Manufacturer Received: 04/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization