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

Model Number STRIP, TRUE METRIX 50CTMG/DL

Device Problem Incomplete or Missing Packaging (2312)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/18/2020

Event Type  malfunction  

Manufacturer Narrative

Internal report reference number: 28902-1 test strips vial was not returned for evaluation.Most likely underlying root cause: mlc-9: user error caused or contributed to event.Note: manufacturer contacted customer in a follow-up call to ensure the replacement products resolved the initial concern - unable to establish contact with customer at this time.No product notification letter sent since no customer address on file.

Event Description

Customer reported complaint for missing package item(s), stating that she had purchased a vial of truemetrix test strips, lot mv2889, one month ago and the vial was empty.Customer stated the vial was sealed prior to opening.Customer stated that he had just opened the vial one week ago.The test strips are expired, manufacturer's expiration date of 02/16/2020.Customer's address was not obtained at time of initial call and so no replacement product was able to be provided.

Manufacturer Narrative

Sections with additional information as of 29-jul-2020: h6: updated fda's method, result, and conclusion codes.H10: complaint was forwarded to packaging based on complaint's description for investigations.No product was returned to thi.Internal evaluation has been completed by packaging and no abnormalities observed.

• 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: 9954477
• MDR Text Key: 201905334
• Report Number: 1000113657-2020-00225
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 07/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/16/2020
• Device Model Number: STRIP, TRUE METRIX 50CTMG/DL
• Device Lot Number: MV2889
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/18/2020
• Date Manufacturer Received: 06/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1