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

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Calibra requested return of the product but it has not been received.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, the patient reported that the patch was caught on the edge of the counter.The device pulled off and could no longer be used.There was no indication that the product caused or contributed to an adverse event.This complaint is being reported because the device became unusable.

Manufacturer Narrative

Follow up # 1 date of submission 11/9/2016 device evaluation: on 10/24/2016 the product analysis lab completed investigation of the returned device.Visual inspection was performed to evaluate the device.During inspection it was found that the device was used but not locked.Blood and hair was found at the adhesive patch.No physical or mechanical damages were found.Dhr review was performed and no issues related with the complaint were found.Based on the investigation and visual inspection results, it can be concluded that the complaint was not confirmed and no further action was required.According to the user's guide, the patient should avoid placing the patch where it will be frequently struck or rubbed against other objects.The user's guide precaution states: do not place the patch on sites that have significant body hair.Placing the patch onto sites with a significant amount of hair will reduce the adhesion of the patch, and will results in the patch detaching early.It is advised to remove body hair or to select an area that does not contain body hair.

• 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: 5991928
• MDR Text Key: 56551324
• Report Number: 3008272700-2016-00030
• Device Sequence Number: 1
• Product Code: OPP
• Combination Product (y/n): N
• 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,Followup
• Report Date: 09/27/2016

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
• Other Device ID Number: 1-2VSIX7R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 09/27/2016
• Initial Date FDA Received: 09/30/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/09/2016
• 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