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

Device Problem Sticking (1597)

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.(b)(6).

Event Description

On (b)(6) 2016, it was reported that on the first dose, the buttons were " sticky" and then stayed in the locked position.The patient was said to have replaced the patch with a new one, and dose was delivered without issue.There was no indication that the product caused or contributed to an adverse event.This complaint is being reported because the device was unable to deliver insulin.

Manufacturer Narrative

Follow-up #1 04/06/2016 device evaluation: the inserter has been returned and evaluated by product analysis on (b)(6) 2016 with the following findings: the patch showed evidence that the device was filled, partially debubbled and deployed.The patch buttons were not locked per the allegation upon receipt of the product.During testing the device was clicked several times without issues.The button travel was not found to be hindered or sticking during testing.There was no foreign material noted on the patch and there was no damage to the buttons, casing, or any of the springs.The cannula appeared slightly bent during investigation however this appeared to be related to lack of protection during shipping.The alleged sticking button allegation was unable to be confirmed or duplicated during testing.

• 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: 5426839
• MDR Text Key: 38539951
• Report Number: 3008272700-2016-00007
• 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: study
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 01/29/2016
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2016
• 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: 01/29/2016
• 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