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

Model Number STRIP, WGN TMX 30CT 24/CASE MG/DL

Device Problems Unsealed Device Packaging (1444); Incomplete or Missing Packaging (2312)

Patient Problem Hyperglycemia (1905)

Event Date 10/15/2021

Event Type  malfunction  

Event Description

Consumer reported complaint for open vial of true metrix blood glucose test strips.Customer stated when he had obtained the test strips, the test strip vial had been taped at the bottom and had no seal.Customer stated he had counted the test strips in the vial and there were only 18 test strips in a 30 count vial.The product is stored according to specification in the bedroom.The test strip lot manufacturer¿s expiration date is 02/28/2023 and open vial date was not disclosed.Prior to the call, the customer had performed a blood test using this vial of test strips and had obtained a blood glucose test result of 125 mg/dl fasting; customer was not concerned with the result obtained.The customer feels well and did not report any symptoms.Medical attention is not reported as a result of the actual blood glucose results.

Manufacturer Narrative

(b)(4).Test strips were not returned for evaluation - customer returned incorrect test strips.Note: manufacturer contacted customer in a follow-up call on (b)(6) 2021 to ensure the replacement product resolved the initial concern - able to establish contact with customer who stated replacement product resolved initial concern.

Manufacturer Narrative

Sections with additional information as of 22-dec-2021: h6: updated fda¿s type, findings and conclusions 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 within specifications.Most likely underlying root cause: mlc-009: use error caused or contributed to event.

• 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
• Manufacturer Contact: karen devincent ; 2400 nw 55th court; fort lauderdale, FL 33309
• MDR Report Key: 12786288
• MDR Text Key: 286061926
• Report Number: 1000113657-2021-00708
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00021292009120
• UDI-Public: (01)00021292009120
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 12/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2023
• Device Model Number: STRIP, WGN TMX 30CT 24/CASE MG/DL
• Device Catalogue Number: REA4H01-01
• Device Lot Number: MY4469S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 10/15/2021
• Date Manufacturer Received: 11/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1