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

Model Number STRIP, CVS 100CTTT

Device Problem Measurement System Incompatibility (2982)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/01/2020

Event Type  malfunction  

Manufacturer Narrative

Internal report reference number: (b)(4).Meter and test strips were not returned for evaluation.Most likely underlying root cause: mlc-129: user misread display.Note: manufacturer contacted customer in a follow-up call to ensure the replacement products resolved the initial concern - able to establish contact with customer and stated replacement product resolved initial concern.Customer will send back faulty meter after covid-19 quarantine is lifted in (b)(6).Note manufacturer contacted customer several follow-up calls to ensure the truetrack product is not reading mmol/l and is properly reading mg/dl - able to establish contact with customer and requested an email with a picture but she seemed a bit bothered and said she is busy.She requests we not call her back.Note: thi is currently investigating case.Supplemental report will be submitted once new information is gathered.

Event Description

Consumer reported complaint for meter displaying e-2 error messages and meter reading in mmol.The expected fasting blood glucose test result range is undisclosed.The customer did not report symptoms.Medical attention is not reported as a result.The product is stored according to specification in the living room.During the call, a back to back blood test was not performed by the customer the test strip lot manufacturer¿s expiration date is 10/31/2021 and open vial date is (b)(6) 2020.The meter memory was not reviewed for previous test result history.

Manufacturer Narrative

Sections with additional information as of 15-jul-2020: h10: meter was returned for evaluation; no defect was detected.Test strips were not returned for evaluation.

• Brand Name: TRUETRACK
• 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: 10019781
• MDR Text Key: 189906402
• Report Number: 1000113657-2020-00278
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00021292008642
• UDI-Public: (01)00021292008642
• Combination Product (y/n): N
• PMA/PMN Number: K032657
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 07/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2021
• Device Model Number: STRIP, CVS 100CTTT
• Device Catalogue Number: A4H01-81
• Device Lot Number: RW5355S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2020
• Distributor Facility Aware Date: 04/01/2020
• Date Manufacturer Received: 06/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1