MAUDE Adverse Event Report: MEDTRONIC MINIMED SENSOR HSA; CGM

Model Number MMT-7003A

Device Problems Difficult to Remove (1528); Retraction Problem (1536)

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

Event Date 10/06/2014

Event Type  malfunction  

Event Description

It was reported that the sensor could not be removed after puncture.The customer's blood glucose was unknown at the time of reporting.It was also stated that the sensor could not be retracted.The sensor was returned.No additional information was reported.

Manufacturer Narrative

Findings: reliability analysis inspected 1 opened/used sensor and performed visual inspection and found sensor tip peeled back outside introducer needle canal.Unable to confirm customer received sensor damage due to customer returned opened/used.Also found needle bent inside sensor base.

• Brand Name: SENSOR HSA
• 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 121
• Manufacturer Contact: christopher tupper ; 18000 devonshire street; northridge, CA 91325-1219 ; 8185764313
• MDR Report Key: 4225533
• MDR Text Key: 5069096
• Report Number: 2032227-2014-47119
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P980022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MMT-7003A
• Device Catalogue Number: MMT-7003A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/20/2014
• Initial Date FDA Received: 11/04/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1