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

Model Number	STRIP, RLN TMX 100CTMG/DL
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Codes	Anemia (1706); Urinary Frequency / Polyuria (2275)
Date of Event	04/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Meter and test strips were not returned for evaluation.Most likely underlying root cause: mlc-61: improper use / mishandled by end user.Adverse event report is being submitted due to symptoms related to diabetes - frequent urination.Note: manufacturer contacted customer in a follow-up call to ensure that the customer's condition improved - able to establish contact with customer and stated that her condition is still the same, still having frequent urination.Customer is in a lot of pain and she is not sure if is because of her diabetes.Customer stated that she is anemic.Customer is not sure if her symptoms are related to her diabetes or her anemia.Customer stated that she has been suffering with this chronic illness for a long time.Customer will be having surgery tomorrow but did not want to specify what she was having surgery on.Note: manufacturer contacted customer in a follow-up call to ensure that the customer's condition improved - able to establish contact with customer and stated she had her surgery on 23-apr-2020 and was discharged the same day.Condition has not improved and she is still having frequent urination and frequent bowl movement but she is not sure if its because of her diabetes.
Event or Problem Description
Consumer reported complaint for e-0 accompanied by symptoms.Results.The expected fasting blood glucose test result range is undisclosed.The customer did report symptom of frequent urination.Customer is anemic and has chronic pancreatitis (c-diff).Medical attention is not reported as a result of the actual blood glucose results or reported symptom.The product storage location is undisclosed.During the call, a blood test was performed by the customer and produced test results of 158mg/dl fasting using true metrix meter.The test strip lot manufacturer¿s expiration date is 08/27/2021 and open vial date is undisclosed.The meter memory was not reviewed for previous test result history.
Additional Manufacturer Narrative
Sections with additional information as of 24-sept-2021: h6: updated fda¿s type, findings and conclusions codes.H10: meter and strips were not returned for investigation.Retention strip lot tested and passed.Most likely underlying root cause: mlc-078 user hematocrit low manufacturer acknowledges the lateness of this report and initiated the necessary corrective action.Manufacturer corrective action number: (b)(4)¿.

• Brand Name: TRUE METRIX AIR
• Common Device Name: SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER
• Manufacturer (Section D): TRIVIDIA HEALTH INC; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 10063526
• Report Number: 1000113657-2020-00303
• Device Sequence Number: 19603795
• Product Code: NBW
• UDI-Device Identifier: 00021292012236
• UDI-Public: (01)00021292012236
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K150052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/27/2021
• Device Model Number: STRIP, RLN TMX 100CTMG/DL
• Device Catalogue Number: REA4H01-01
• Device Lot Number: MW4143S
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/17/2020
• Initial Date Received by Manufacturer: 04/17/2020
• Supplement Date Received by Manufacturer: 05/28/2020
• Initial Report FDA Received Date: 05/15/2020
• Supplement Report FDA Received Date: 09/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other