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

Lot Number 400

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The product is not being returned as the device has been discarded.The lots were manufactured, inspected, and released per approved calibra procedures.No issues related to the complaint were identified during the processing of the lots.No conclusions can be made at this time.(b)(6).

Event Description

On (b)(6) 2017, it was reported that the buttons did not lock when the device was empty.The patient said that it only happened with one device.The following sequence of events was reported: it was the last day of use and the patient was ready to change the device.He delivered a breakfast bolus; the buttons did not lock at the end of the dose.He took off the device and said it looked empty.He clicked it in the air several times to empty the device but nothing came out.At the end of his test, the buttons never locked.The patient reported that he did not experience a noticeable blood glucose excursion.This complaint is being reported because the issue may cause lack of insulin delivery without patient awareness due to device not detecting an empty reservoir.

• 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: 6510983
• MDR Text Key: 73667038
• Report Number: 3008272700-2017-00011
• 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
• Report Date: 04/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: 400
• 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: 04/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1