MAUDE Adverse Event Report: MEDTRONIC MINIMED SENSOR ENLITE; CGM

Model Number MMT-7008A

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/29/2014

Event Type  malfunction  

Event Description

It was reported that two sensors broke off underneath the customer's skin.It was stated that the customer was not getting a signal after inserting the sensors, and when he pulled them out, the cannulas were missing.Nothing further was reported.

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.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.

Manufacturer Narrative

Inspected one opened/used sensor.Performed insertion test and sensor passed per specifications.No broken or missing parts noted.

• Brand Name: SENSOR ENLITE
• Type of Device: CGM
• Manufacturer (Section G): MEDTRONIC MINIMED; 18000 devonshire street; northridge CA 91325 121
• Manufacturer Contact: christopher tupper ; 18000 devonshire street; northridge, CA 91325-1219 ; 8185764313
• MDR Report Key: 3609545
• MDR Text Key: 4064859
• Report Number: 2032227-2014-00627
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2014
• 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: L173N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/29/2014
• 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 Outcome(s): Hospitalization