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

Device Problems Unintended Collision (1429); Malposition of Device (2616); Device Dislodged or Dislocated (2923)

Patient Problems Dehydration (1807); Hyperglycemia (1905); Palpitations (2467)

Event Type  Injury  

Event Description

On 07/11/2015, it was reported through an anonymous survey that the patch came off after hitting it on a doorway.It was reported that the patch was placed "too far on one side." at the same time, it was reported that the patient went to the emergency room where his blood glucose (bg) was allegedly 180-235 mg/dl.The patient noted that he had palpitations in his chest.It was said that the doctor diagnosed the patient with dehydration.No additional details, including treatment and resolution of the high bg, are known.This complaint is being reported because the device cannot be ruled out as a cause or contributor of the emergency room visit.

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.

• Brand Name: FINESSE PATCH
• Type of Device: FINESSE INSULIN DELIVERYSYSTEM
• Manufacturer (Section D): CALIBRA MEDICAL, INC; 220 saginaw dr; redwood city CA 94063 472
• Manufacturer (Section G): CALIBRA MEDICAL, INC; 220 saginaw dr; redwood city CA 94063 472
• Manufacturer Contact: sam crawford ; 220 saginaw dr; redwood city, CA 94063-4725 ; 6502984705
• MDR Report Key: 4922111
• MDR Text Key: 6030171
• Report Number: 3008272700-2015-00024
• Device Sequence Number: 1
• Product Code: OPP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 111924
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/14/2015

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?: Yes
• 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: 07/14/2015
• 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
• Patient Outcome(s): Life Threatening; Required Intervention