MAUDE Adverse Event Report: TRIVIDIA HEALTH, INC PEN NEEDLES FG; SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER

Model Number	PNDL, 3BV TVH TP 32G 4MM100CT 30/CS
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pen needles were not returned for evaluation.Most likely underlying root cause: mlc -61: improper use / mishandled by end user.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.
Event or Problem Description
Consumer reported complaint for pen needle inaccurate dispense/aspiration, stating that some of the pen needles are not dispensing insulin.Customer had concerns that the product is unable to administer their insulin due to the issue.The customer feels well and did not report any symptoms or that medical attention had been required.

• Brand Name: PEN NEEDLES FG
• Common Device Name: SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER
• Manufacturer (Section D): TRIVIDIA HEALTH, INC; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 9120686
• Report Number: 1000113657-2019-10012
• Device Sequence Number: 16606499
• Product Code: FMI
• UDI-Device Identifier: 00021292009076
• UDI-Public: (01)00021292009076
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• 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): 09/25/2019

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 Expiration Date: 10/01/2023
• Device Model Number: PNDL, 3BV TVH TP 32G 4MM100CT 30/CS
• Device Catalogue Number: S5H01A32-100
• Device Lot Number: Y58ZD4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2019
• Distributor Facility Aware Date: 08/28/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/28/2019
• Initial Report FDA Received Date: 09/25/2019
• Patient Sequence Number: 1