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

Model Number STRIP, MCKESSON TMX NFRS50CT MG/DL

Device Problem Image Display Error/Artifact (1304)

Patient Problems Fall (1848); Muscle Weakness (1967)

Event Date 10/09/2022

Event Type  Injury  

Manufacturer Narrative

Internal report reference number: (b)(4).Adverse event report is being submitted due to symptoms related to diabetes: weak and for customer contacting paramedics due to fall (unsure if related to diabetes).Meter and test strips were not returned for evaluation.Added most likely underlying root cause onto case as the complaint product was not returned for investigation.Most likely underlying root cause: mlc-006: passed open expiration date" manufacturer contacted customer in several follow-up calls to ensure the customer's condition had improved and that the initial concern is resolved - unable to establish contact with customer at this time.

Event Description

Consumer reported complaint for error message (e-0).At the time of the call the customer reported feeling weak.Customer stated that he had fallen the day before and paramedics had been called to his home.Customer was not sure if the fall was related to diabetes.Customer stated the paramedics had just helped him up and left.No further information was provided.During the call, a back to back blood test was not performed by the customer.The product is stored according to specification in the bedroom.The test strip lot manufacturer¿s expiration date is 06/2/2023 and test strips were opened 6 months ago (expired).The customer did not have another vial of test strips that had been stored and handled correctly.

Manufacturer Narrative

Sections with additional information as of 02-dec-2022: h6: updated fda¿s type, findings and conclusions codes.H10: meter was not returned for evaluation.Test strips were not returned for evaluation.Retention testing was performed using test strips from the same lot.Retention strip lot tested within specifications.

• 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: 15734667
• MDR Text Key: 303077270
• Report Number: 1000113657-2022-00580
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 10612479214979
• UDI-Public: (01)10612479214979
• 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,Followup
• Report Date: 12/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/28/2023
• Device Model Number: STRIP, MCKESSON TMX NFRS50CT MG/DL
• Device Catalogue Number: RE4H01-81
• Device Lot Number: ZY4600S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 10/10/2022
• Date Manufacturer Received: 11/15/2022
• 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): Other