MAUDE Adverse Event Report: CALIBRA MEDICAL, INC FINESSE PATCH; FINESSE INSULIN DELIVERYSYSTEM

Lot Number 040

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Calibra has been unable to be returned.No conclusions can be made at this time.(b)(6).

Event Description

On (b)(6) 2017 it was reported that the needle of the device fell off when trying to insert it.There was no indication that the product caused or contributed to an adverse event.This complaint is being reported because long or short term cessation of insulin delivery may occur if patient is unable to use the device; the issue could signal that a foreign body may be stuck in site which may require medical intervention to remove.

• Brand Name: FINESSE PATCH
• Type of Device: FINESSE INSULIN DELIVERYSYSTEM
• Manufacturer (Section D): CALIBRA MEDICAL, INC; 965 chesterbrook blvd; wayne PA 19087
• Manufacturer (Section G): CALIBRA MEDICAL, INC; 965 chesterbrook blvd; wayne PA 19087
• Manufacturer Contact: karin sargrad ; 965 chesterbrook blvd; wayne, PA 19087 ; 4843561808
• MDR Report Key: 6460496
• MDR Text Key: 71916813
• Report Number: 3008272700-2017-00008
• Device Sequence Number: 1
• Product Code: OPP
• Combination Product (y/n): N
• PMA/PMN Number: K111924
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,study
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: 040
• Other Device ID Number: 1-2VSIX7R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 03/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1