MAUDE Adverse Event Report: MEDTRONIC MINIMED LANCET DEVICE SNSRTR CMFRT EN; CGM

Model Number MMT-7510

Device Problem Retraction Problem (1536)

Patient Problem Hyperglycemia (1905)

Event Date 11/11/2014

Event Type  Injury  

Manufacturer Narrative

A complete analysis and testing of 1 opened and 1 used enlite insertion device showed that they functioned properly and passed all functional testing.After testing it was concluded that the device operated within specifications.

Event Description

It was reported the customer's serter was pulling the sensor off their skin.The customer also reported the needle hub of the serter would not release.The customer's blood glucose was 463 mg/dl at the time of the call.Customer stated they had treated with a bolus delivery.It was also found the customer was experiencing high blood glucose because they were sick.The customer's sensor will be replaced.No additional information provided.

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.Reference manufacturer report number: 2032227-2014-645555.

• Brand Name: LANCET DEVICE SNSRTR CMFRT EN
• 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: 4318497
• MDR Text Key: 13032001
• Report Number: 2032227-2014-64554
• 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,Followup
• Report Date: 11/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-7510
• Device Catalogue Number: MMT-7510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/11/2014
• Initial Date FDA Received: 12/10/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Weight: 72