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

Model Number	METER, PRO MCKESSON TMXMG/DL
Health Effect - Clinical Codes	Urinary Frequency / Polyuria (2275); Shaking/Tremors (2515)
Date of Event	12/22/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Meter and test strips were not returned for evaluation - customer declined replacement as no product malfunction occurred.Adverse event report is being submitted due to symptoms related to diabetes ¿ shakiness & urinary frequency.Note: manufacturer contacted customer in a follow-up call on 29-dec-2020 to ensure the patient condition improved and initial concern is resolved - able to establish contact with customer who stated that did not currently have any diabetic symptoms.The customer reported calling the pharmacy due to having increased urination.Customer stated that the pharmacist had advised her to contact her doctor, so she had called her doctor's office; but customer did not disclose who exactly she had spoken with or the advise given.Customer had tested using the meter and had obtained results in the 70's and then in the 100's.Customer stated she had been advised that "maybe did not eat enough.".
Event or Problem Description
Consumer had called for training on performing a blood test.During the call a blood test was performed by the customer fasting and produced test result of 52 mg/dl using the meter.Customer was not concerned with the result.Customer stated that she has a poor diet and has not been eating.At the time of the call, the customer reported feeling shaky but medical attention was not needed at the time.Customer had no further concerns regarding the product.
Additional Manufacturer Narrative
Sections with additional information as of 11-feb-2021: h6: updated fda's method, result, and conclusion 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 and passed.Most likely underlying root cause: mlc-073: user not familiar with system ifu.

• Brand Name: TRUE METRIX PRO
• 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: 11181464
• Report Number: 1000113657-2021-00034
• Device Sequence Number: 3920125
• Product Code: NBW
• UDI-Device Identifier: 10612479210254
• UDI-Public: (01)10612479210254
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K140100
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2021

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: 01/22/2022
• Device Model Number: METER, PRO MCKESSON TMXMG/DL
• Device Catalogue Number: RE4H01P-43
• Device Lot Number: MX4335S
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 12/22/2020
• Initial Date Received by Manufacturer: 12/22/2020
• Supplement Date Received by Manufacturer: 01/19/2021
• Initial Report FDA Received Date: 01/15/2021
• Supplement Report FDA Received Date: 02/11/2021
• 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