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

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

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.Calibra performed a lot review of the product distributed during the study and confirmed that the lots were within specifications at the time of release.No conclusions can be made at this time.

Event Description

On (b)(6) 2015, the patient responded to an anonymous survey for calibra that the first time the device was inserted, the patient had an infection.On (b)(6) 2015, calibra received the results of the exit interview with the study participant indicating that the infection required a prescribed antibiotic.The participant indicated that the lump at the site remained for quite a while.This report is made based on the indication obtained on (b)(6) 2015 that the patient's infection with use of the product required prescribed antibiotics.

• 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: 5148745
• MDR Text Key: 28241903
• Report Number: 3008272700-2015-00048
• 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: study
• Reporter Occupation: Patient
• Report Date: 09/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 09/21/2015
• 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
• Patient Outcome(s): Life Threatening