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

Model Number STRIP, TMX CVS 100CT12/CASE MG/DL

Device Problem Device Displays Incorrect Message (2591)

Patient Problems Vitreous Floaters (1866); Shaking/Tremors (2515)

Event Date 03/10/2020

Event Type  Injury  

Manufacturer Narrative

Internal report reference number: (b)(4).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 Description

Consumer reported complaint for e-2 error.The product is stored according to specification in the living area.The test strip lot manufacturer¿s expiration date is 10/31/2020 and test strips were opened 2-3 weeks ago.During the call, a blood test was performed by the customer fasting and produced test result of 101 mg/dl using truemetrix air meter.Customer was satisfied with the result obtained.At the time of the call the customer reported feeling shaky and seeing spots in her vision.Medical attention was not needed at the time of the call.Customer stated she had not yet eaten her breakfast.

Manufacturer Narrative

Sections with additional information as of 21-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 21-may-2020: h1: type of reportable event corrected from "malfunction" to "serious injury".

• Brand Name: TRUE METRIX AIR
• 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: 9933167
• MDR Text Key: 208637451
• Report Number: 1000113657-2020-00206
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00021292007836
• UDI-Public: (01)00021292007836
• Combination Product (y/n): N
• PMA/PMN Number: K150052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/21/2020

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2020
• Device Model Number: STRIP, TMX CVS 100CT12/CASE MG/DL
• Device Catalogue Number: REA4H01-01
• Device Lot Number: MW3293S
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/10/2020
• Initial Date Manufacturer Received: 03/10/2020
• Initial Date FDA Received: 04/07/2020
• Supplement Dates Manufacturer Received: 04/23/2020
• Supplement Dates FDA Received: 05/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other