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

Model Number STRIP, TRUE METRIX MEDIMEDI 50CT MG/DL

Device Problem Image Display Error/Artifact (1304)

Patient Problems Vomiting (2144); Weakness (2145); Dizziness (2194)

Event Date 01/29/2021

Event Type  Injury  

Manufacturer Narrative

Internal report reference number: (b)(4).Meter and test strips were not returned for evaluation.Note: manufacturer contacted customer in several follow-up calls to ensure customer's condition improved and the initial concern is resolved - unable to establish contact after several follow up attempts.

Event Description

Consumer reported complaint for e-5 error.Daughter-in-law is calling on behalf of the customer.At the time of the call, the customer reported symptoms of feeling weak, dizziness and vomiting.Daughter-in-law stated she was going to seek medical attention and bring customer to her doctor's.The product storage location is undisclosed.During the call a back to back blood test was not performed by the customer.The test strip lot manufacturer¿s expiration date is 06/21/2022 and open vial date is undisclosed.No further information was able to be obtained.The meter memory was not reviewed for previous test result history.

Manufacturer Narrative

Sections with additional information as of 07-april-2021: d8: was this device serviced by a third party.H3: additional information.H6: updated fda's type of investigation, investigation findings, and investigation conclusions.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 within specifications.Add: most likely underline root cause mlc-018 user has high glucose value.

• 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: 11376302
• MDR Text Key: 233499885
• Report Number: 1000113657-2021-00139
• 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,other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/21/2022
• Device Model Number: STRIP, TRUE METRIX MEDIMEDI 50CT MG/DL
• Device Catalogue Number: REA4H01-01
• Device Lot Number: ZX4146S
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 01/29/2021
• Date Manufacturer Received: 03/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other