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

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

On (b)(6) 2015 the reporter contacted calibra indicating that the patch was filled as normal but prior to inserting the patch, insulin was noted to have leaked out.This complaint is being reported because the reported issue was not resolved with troubleshooting.There was no indication that the product caused or contributed to an adverse event.

Manufacturer Narrative

The product has not been returned to calibra.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.

Manufacturer Narrative

Follow up #1: additional information: calibra contacted the patient on (b)(6) 2015 for additional troubleshooting of the reported event.The reporter indicated that the device was filled with 200 units of insulin.During the prime step the patient indicated holding the device vertical out in front of the body and pressed the buttons until the device clicked 3 times to prime, but the device was noted to be leaking from an area other than the cannula at that time.The patient confirmed feeling that he received the proper training.

Manufacturer Narrative

Follow-up #2 09/08/2015 device evaluation: the patch has been returned and evaluated by product analysis on 08/31/2015 with the following findings: the finesse patch was examined.The insulin reservoir was found to have an air bubble present.The fill septum appeared normal.The guide cap was found to have excess insulin in the insulin trap fins and the liner was found to have insulin around the guide cap possibly indicating that the device was clicked many times.When the beige cap was removed, no residual insulin was found, the welds were confirmed competent, and the reservoir bonds were in excellent condition confirming no internal leaks.During testing, the device de-bubbled with 5 clicks.The device clicked 47 times until the last dose lock out delivering approximately 94 units.The product was within specifications and performed appropriately during testing.Lot record review of all lots released for the market acceptance study was completed and lots were found to be operating within required specifications at the time of release.

• Brand Name: FINESSE PATCH
• Type of Device: FINESSE INSULIN DELIVERYSYSTEM
• Manufacturer (Section D): CALIBRA MEDICAL, INC; 220 saginaw dr; redwood city CA 94063 4725
• Manufacturer (Section G): CALIBRA MEDICAL, INC; 220 saginaw dr; redwood city CA 94063 4725
• Manufacturer Contact: sam crawford ; 220 saginaw dr; redwood city, CA 94063-4725 ; 6502984705
• MDR Report Key: 4921775
• MDR Text Key: 6431875
• Report Number: 3008272700-2015-00020
• Device Sequence Number: 1
• Product Code: OPP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111924
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/10/2015

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
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 07/10/2015
• Initial Date FDA Received: 07/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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