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

Device Problems Bent (1059); Failure to Deliver (2338)

Patient Problem Hyperglycemia (1905)

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 the patient's blood glucose was 184mg/dl with no signs or symptoms of hyperglycemia after taking a dose of insulin from the device.There was no medical intervention; the patient replaced the device with a new one, dosed with insulin, and hyperglycemia resolved.This hyperglycemic incident does not meet the definition of an adverse event.It was said that when the patient removed the device from the skin, the cannula was bent.This complaint is being reported because the device was unable to deliver insulin due to a bent cannula.

• 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: 5388877
• MDR Text Key: 36779167
• Report Number: 3008272700-2016-00006
• 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,study
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2016
• 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: 01/20/2016
• 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