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

Model Number METER, GO TRUE METRIXMTR ONLY TRIVIDIA MG/DL

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Death (1802)

Event Date 02/06/2020

Event Type  Death  

Manufacturer Narrative

Internal report reference #(b)(4).Meter and test strips were not returned for evaluation.No root cause could be determined at this time with the information available.Note: manufacturer attempted to make contact with the nurse several times in order to obtain more information about the event.Voice messages were left to call manufacturer back - unable to make contact with nurse at this time.No product notification letter sent since no customer address on file.A nurse at an assisted living facility called about an e-0 reading on the true metrix go.During call, the employee said that a previous user of the device had died and stated it was due to the product.She did not clarify the comment, nor did she respond to repeated attempts to obtain more information, then she disconnected the call.Unable to verify date and time of patient's death.

Event Description

Assisted living facility nurse is calling to inquire about the e-0 error and why error is coming up.Nurse did not have the products (meter/test strips) available to troubleshoot at the time of the call, neither product details (serial number/lot number).Nurse stated that the product does not belong to the current resident she was trying to perform a blood glucose test.Nurse stated that the meter belonged to a previous resident who had passed away and stated that the meter was kept and it was being used on current resident who test couple of times at day.

Manufacturer Narrative

Sections with additional information as of 26-aug-2020: h10: most likely underlying root cause: mlc-28: there was not enough information to determine the mlurc.

• Brand Name: TRUE METRIX GO
• Type of Device: SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER
• Manufacturer (Section D): TRIVIDIA HEALTH INC; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 9802503
• MDR Text Key: 182507633
• Report Number: 1000113657-2020-00137
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• PMA/PMN Number: K143548
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: METER, GO TRUE METRIXMTR ONLY TRIVIDIA MG/DL
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/06/2020
• Date Manufacturer Received: 07/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death