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

Model Number METER, TRUE METRIX BLANKMG/DL

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Information (3190)

Event Date 11/05/2020

Event Type  Injury  

Manufacturer Narrative

Internal report reference number: (b)(4).Meter and test strips were not returned for evaluation.Customer also had another device they were reporting for the same error message (e-0) - internal report reference number: (b)(4).Note: manufacturer contacted customer in follow-up calls to ensure the patient condition improved and initial concern is resolved - unable to establish contact with customer at this time.

Event Description

Consumer reported complaint for error message (e-0).Significant other is calling on behalf of the customer.Customer did not have the product and was unable to provide serial number or test strip lot information, but had only reported that it was our brand meter.At the time of the call the customer felt well and did not report any symptoms.Caller informed the rep that customer was hospitalized earlier, but declined to provide any further information regarding customer's medical attention.

• 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: 11143211
• MDR Text Key: 226034674
• Report Number: 1000113657-2021-00015
• 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,other
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 01/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: METER, TRUE METRIX BLANKMG/DL
• Device Catalogue Number: RE4H01-81
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 12/15/2020
• Date Manufacturer Received: 12/15/2020
• 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