MAUDE Adverse Event Report: MEDTRONIC MINIMED SENSOR ENLITE; CGM

Model Number MMT-7008A

Device Problem Component Falling (1105)

Patient Problem Hyperglycemia (1905)

Event Date 08/11/2015

Event Type  malfunction  

Manufacturer Narrative

Currently, it is unknown whether or not the device may have caused or contributed to the event as no product has been returned.The device will be returned for analysis and further information will follow once the analysis has been completed.No conclusion can be drawn at this time.

Event Description

The customer called in to report that the while taking the sensor out of the package, the needle hub fell out.The customer's blood glucose level was 160 mg/dl.The customer was advised to discontinue use of the device and was asked to return the product.The customer's sensor was replaced.

Manufacturer Narrative

A visual inspection was performed on 1 opened and used enlite sensor, found the insertion needle was separated from the sensor base; unable to confirm if the customer received the sensor in said condition due to the sensor was returned opened and used.This complaint is against the insertion device.

• Brand Name: SENSOR ENLITE
• Type of Device: CGM
• Manufacturer (Section D): MEDTRONIC MINIMED; 18000 devonshire street; northridge CA 91325
• Manufacturer (Section G): MEDTRONIC MINIMED; 18000 devonshire street; northridge CA 91325 1219
• Manufacturer Contact: gerwin de graaff ; 18000 devonshire street; northridge, CA 91325-1219 ; 8185764805
• MDR Report Key: 5043822
• MDR Text Key: 25268235
• Report Number: 2032227-2015-38164
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• PMA/PMN Number: 120010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Followup
• Report Date: 07/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-7008A
• Device Catalogue Number: MMT-7008A
• Device Lot Number: HG0KDQW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 47 YR
• Patient Weight: 66