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

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Calibra requested return of the product but it has not been received.If the device is returned, an evaluation shall be completed and a supplemental report will be filed.No conclusions can be made at this time.(b)(6).

Event Description

On (b)(6) 2017, it was reported that the device ¿kept falling off¿ so the patient placed tape over the patch to prevent this issue.There was no report of blood glucose excursion associated with this issue.This complaint is being reported as the issue may prevent use of device, or premature adhesive failure may cause patch to fall off,.

Manufacturer Narrative

Correct lot # for this complaint is 414.

• 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: 6367689
• MDR Text Key: 69018023
• Report Number: 3008272700-2017-00002
• 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,Followup
• Report Date: 02/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• 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: 02/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1