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

Device Problem Contamination (1120)

Patient Problem Unspecified Infection (1930)

Event Type  malfunction  

Manufacturer Narrative

The lot number for this device was not provided and return is not expected as the product was discarded.No conclusions can be made at this time.(b)(6).

Event Description

On 3/17/2017 it was reported that the patient developed a small, localized infection and was started on antibiotics; keflex 500 mg bid was prescribed.There was redness and soreness noted by the patient; a small amount of drainage was reported.At the same time, it was reported that the patient was not changing insertion sites at lease every 3 days.The patient was re-instructed to switch sites at least every 3 days and more often if necessary.Patch therapy was resumed according to the health care professional.This complaint is being reported because an adverse event due to use error was reported.There was no indication of a malfunction or defect.

• Brand Name: FINESSE PATCH
• Type of Device: FINESSE INSULIN DELIVERYSYSTEM
• Manufacturer (Section D): CALIBRA MEDICAL, INC; 965 chesterbrook blvd; wayne PA 19087
• Manufacturer (Section G): CALIBRA MEDICAL, INC; 965 chesterbrook blvd; wayne PA 19087
• Manufacturer Contact: karin sargrad ; 965 chesterbrook blvd; wayne, PA 19087 ; 4843561808
• MDR Report Key: 6435846
• MDR Text Key: 71213729
• Report Number: 3008272700-2017-00007
• 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
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Other Device ID Number: 1-2VSIX7R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 03/17/2017
• 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