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

Model Number	STRIP, TRUE METRIX PRO50CT MG/DL
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Codes	Weakness (2145); Lethargy (2560)
Date of Event	09/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Meter and test strips were not returned for evaluation.Most likely underlying root cause: mlc-14: insufficient blood sample applied to strip (user).Note: manufacturer contacted customer in a follow-up call to ensure that the customer's condition improved - unable to establish contact with customer at this time.No product notification letter sent since no customer address on file.
Event or Problem Description
Consumer reported complaint for e-2 error.The e-2 error occurred when the blood sample was applied to the test strip.At the time of the call the customer was not feeling well and reported symptoms of feeling very tired and weak.Medical attention was not required at the time of the call.Call was escalated due to symptoms; technician attempted to call customer but was unable to reach via telephone.
Additional Manufacturer Narrative
Internal report reference number: (b)(4).Sections with additional information as of 08-may-2020: 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.Corrected sections as of 08-may-2020: b2: adverse event report is being submitted due to symptoms related to diabetes - weakness and feeling tired.H1: type of reportable event corrected from "malfunction" to "serious injury".H3: device was returned to manufacturer for evaluation corrected from "yes" to "no".

• Brand Name: TRUE METRIX
• 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: 9226011
• Report Number: 1000113657-2019-10092
• Device Sequence Number: 150658
• Product Code: NBW
• UDI-Device Identifier: 00021292007867
• UDI-Public: (01)00021292007867
• Combination Product (Y/N): N
• 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): 05/08/2020

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: 12/21/2020
• Device Model Number: STRIP, TRUE METRIX PRO50CT MG/DL
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MW3373S
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 09/27/2019
• Initial Date Received by Manufacturer: 09/27/2019
• Supplement Date Received by Manufacturer: 04/21/2020
• Initial Report FDA Received Date: 10/23/2019
• Supplement Report FDA Received Date: 05/08/2020
• 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