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

Device Problems Short Fill (1575); Device Inoperable (1663); Mechanics Altered (2984)

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

Event Type  malfunction  

Manufacturer Narrative

Calibra has been unable to request return of the product at this time.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.

Event Description

On (b)(6) 2016, it was reported that the button became locked on one side of the patch while the patient was delivering a dose of insulin.The patient mentioned that she might not have filled the patch sufficiently.Reportedly, this issue has not occurred since the patient was re-educated on filling the patch with more insulin.There was no indication that the product caused or contributed to an adverse event.This complaint is being reported because there is a possibility that the patch locked without reason, causing the device to become unusable.

Manufacturer Narrative

Follow-up #1 04/12/2016 device evaluation: the patch has been returned and evaluated by product analysis on (b)(6) 2016 with the following findings: the two returned patches were found to have the buttons locked out.When the patch buttons are locked out, the valve button has a small amount of movement inward while the pump button is completely locked.During testing, the buttons were able to be released by injecting air into the reservoir and pressing the buttons.The patches were locked out again by pressing the buttons until they reached their last dose lockout.The patches were again confirmed to be able to unlock the buttons by injecting air into the reservoir.Based on the testing, it appears that the patch buttons were locked out due to reaching the last dose lockout.

• 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: 5387785
• MDR Text Key: 36936335
• Report Number: 3008272700-2016-00004
• Device Sequence Number: 0
• Product Code: OPP
• PMA/PMN Number: K111924
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 01/14/2016
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2016
• 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
• Date Manufacturer Received: 01/14/2016
• 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: Unknown
• Patient Sequence Number: 1