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

Model Number	PNDL, 3BV TVH TP 31G 6MM100CT 30/CS
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994)
Date of Event	10/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pen needle was 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 that the customer's condition improved, able to establish contact with customer and stated medical attention was provided.
Event or Problem Description
Consumer reported complaint for pen needle bent/broken/warped.The expected fasting blood glucose test result range is undisclosed.Customer is using an incompatible insulin pen with pen needle.The customer did report symptoms of pain due to infection.Medical attention is reported as a result of pen needle use.The product storage location is undisclosed.The test strip lot manufacturer¿s expiration date is 11/01/2023 and open vial date is undisclosed.

• 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: 9271653
• Report Number: 1000113657-2019-10116
• Device Sequence Number: 2409067
• Product Code: FMI
• UDI-Device Identifier: 00021292009052
• UDI-Public: (01)00021292009052
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 11/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/01/2023
• Device Model Number: PNDL, 3BV TVH TP 31G 6MM100CT 30/CS
• Device Catalogue Number: S5H01C31-100
• Device Lot Number: Y58ZE4
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 10/08/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/08/2019
• Initial Report FDA Received Date: 11/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1