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

Device Problem Device Dislodged or Dislocated (2923)

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.

Event Description

On (b)(6) 2015, it was reported that a patch came off after a shower.There was no adverse event reported.No additional information was provided related to the complaint as the information was provided through a survey.This complaint is being reported because the issue remains unresolved.

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 on one occasion the patch fell off after taking a shower, right after putting the patch on.This report is made under the requirements of the medical device reporting regulations and does not constitute an admission on the part of calibra of any deficiency in the performance of the device.

• 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: 4990588
• MDR Text Key: 24064700
• Report Number: 3008272700-2015-00038
• 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: 08/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2015
• 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: 08/05/2015
• 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