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

Model Number	PEN NEEDLE
Medical Device Problem Code	Failure to Eject (4010)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Returned product evaluated with no defects found.Most likely underlying root cause: mlc-8: failure to follow instructions.Manufacturer contacted customer on (b)(6) 2018 in a follow-up: customer states that send the product for investigation.No symptoms or medical attention reported.
Event or Problem Description
Consumer reported complaint for needle stick due to the pen needle being stuck on the pen.The customer feels well and did not report symptoms.Medical attention is not reported as a result of the actual blood glucose results.The product storage location is undisclosed.Customer called in states he is unable to take the pen needle of the injector.Customer states he put the clear protective cap and it does not come off when he pulls it off.Customer states he had a needle stick due to the pen needle being stuck on the pen.Customer has a compatible quick pen which is on our approved list.Customer denies the need for medical attention at the time of call.

• Brand Name: 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: 7852290
• Report Number: 1000113657-2018-00927
• Device Sequence Number: 13878884
• Product Code: FMI
• UDI-Device Identifier: 00021292009069
• UDI-Public: (01)00021292009069(17)220701(10)X56S1
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 09/06/2018

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 NEEDLE
• Device Catalogue Number: N/A
• Device Lot Number: X56S1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2018
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2018
• Initial Report FDA Received Date: 09/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1