MAUDE Adverse Event Report: TRIVIDIA HEALTH, INC. TRUEPLUS PEN NEEDLE; BLOOD GLUCOSE SYSTEM

Model Number	PEN NEEDLES
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not returned for evaluation.Customer declined replacement product, as it is using another product.Most likely underlying root cause: mlc-62-user had poor technique.Manufacturer contacted customer on (b)(6) 2018 in a follow-up call to ensure that the initial concern was resolved; customer stated the issues has been resolved and obtained a replacement for another brand at a local pharmacy.Customer refuses to send back the pen needles for evaluation and decided just throw them away, therefore manufacturer is unable to confirm customer's complaint at this time.
Event or Problem Description
Consumer reported complaint for bending pen needle.Customer called because they are using the true plus pen needles that are 31g x 1/4 in.And is stating the needle is bending when going into the skin.Customer did not report symptoms or medical attention.

• Brand Name: TRUEPLUS PEN NEEDLE
• Common Device Name: BLOOD GLUCOSE SYSTEM
• Manufacturer (Section D): TRIVIDIA HEALTH, INC.; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 7625368
• Report Number: 1000113657-2018-00669
• Device Sequence Number: 2193939
• Product Code: FMI
• UDI-Device Identifier: 00096295129113
• UDI-Public: (01)00096295129113(17)221101(10)X46ZJ9
• Combination Product (Y/N): N
• PMA/510(K) Number: K143437
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: PEN NEEDLES
• Device Lot Number: X46ZJ9
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2018
• Initial Report FDA Received Date: 06/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1