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

Device Problems Loss of or Failure to Bond (1068); Human-Device Interface Problem (2949)

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

Event Type  malfunction  

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.No conclusions can be made at this time.

Event Description

On (b)(6) 2015, the reporter responded to an anonymous survey for calibra indicating that physical labor had caused sweating which caused the patch to come loose.The reporter indicated using a backup treatment plan until a new patch could be applied.This complaint is being reported because the reported issue was not resolved with troubleshooting.There was no indication that the product caused or contributed to an adverse event.

Manufacturer Narrative

Follow up #1 submitted 08/26/2015: calibra received follow up from the patient on 08/19/2015.The patient indicated that the sites were prepared by washing the site but no alcohol wipes were used.The patient also indicated that hair was not removed from the site prior to application.The patient indicated that the patches typically fell off because of excess sweat.The patient indicated that the adhesive was loosening and coming off from underneath and not really from the outside edges unless the site was bumped.

• 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: 4921759
• MDR Text Key: 22457735
• Report Number: 3008272700-2015-00019
• 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: consumer
• Reporter Occupation: Other
• Report Date: 07/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2015
• 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: 07/06/2015
• 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