MAUDE Adverse Event Report: MEDTRONIC MINIMED SENSOR; CGM

Model Number MMT-7002C

Device Problems Loose or Intermittent Connection (1371); Device Inoperable (1663)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/28/2015

Event Type  malfunction  

Manufacturer Narrative

The reliability analysis inspected one opened and or used sensor.Visual inspection was performed, and it was found that the insertion needle was bent inside sensor base.The sensor electrode was also found to be split in the needle canal.It was unable to be confirmed that the customer received the sensor in that condition due to the customer having returned the sensor opened and/or used.

Event Description

The customer reported via phone call of issues with their sensor.The customer states that when the sensor was removed from the packaging, it was not sturdy and very loose.The customer's blood glucose level was reported to be 93mg/dl.The customer was advised that the sensor would be replaced and returned for analysis.

• Brand Name: SENSOR
• 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: 5405739
• MDR Text Key: 37565899
• Report Number: 2032227-2016-01340
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• PMA/PMN Number: P980022
• 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: 01/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-7002C
• Device Catalogue Number: MMT-7002C
• Device Lot Number: L024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/15/2015
• 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: 49 YR
• Patient Weight: 67