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

Model Number STRIP, TMX HNO 50CT24/CS MG/DL

Device Problem Peeled/Delaminated (1454)

Patient Problem Insufficient Information (4580)

Event Date 04/22/2021

Event Type  malfunction  

Manufacturer Narrative

Internal report reference number: (b)(4).Test strips were returned - product evaluation in-process.Most likely underlying root cause is pending investigation completion.Note: manufacturer contacted customer in a follow-up call on 06-may-2021 to ensure the replacement product resolved the initial concern - able to establish contact with customer who stated replacement product resolved initial concern.

Event Description

Consumer reported complaint for physical defect of test strips.Customer stated that some of the test strips in the vial were peeling.Customer stated the product was sealed and intact when received.The test strip lot manufacturer¿s expiration date is 05/31/2022 and open vial date was not disclosed.The customer feels well and did not report any symptoms.No medical intervention related to the use of the product was reported.

Manufacturer Narrative

Sections with additional information as of 29-july-2021: h6: updated fda's type of investigation, investigation findings, and investigation conclusions.H10: complaint was forwarded to packaging based on complaint's description for investigations, internal evaluation has been completed, no abnormalities observed root cause: rc-074 manufacturing processing error.

• Brand Name: TRUE METRIX
• 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: 11860173
• MDR Text Key: 259095198
• Report Number: 1000113657-2021-00325
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00021292007836
• UDI-Public: (01)00021292007836
• Combination Product (y/n): N
• PMA/PMN Number: K140100
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 07/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2022
• Device Model Number: STRIP, TMX HNO 50CT24/CS MG/DL
• Device Catalogue Number: RE4H01-81
• Device Lot Number: ZX4164S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2021
• Distributor Facility Aware Date: 04/22/2021
• Date Manufacturer Received: 07/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1