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

Model Number MMT-7510

Device Problems Retraction Problem (1536); Component Missing (2306)

Patient Problem Hypoglycemia (1912)

Event Date 12/28/2014

Event Type  malfunction  

Event Description

Customer reports that sensor did not fully penetrate the skin.Customer states that needle did not retract inserter.Customer states that when sensor was removed, cannula was missing.Customer's blood glucose was 38 mg/dl, which was treated with coke.Customer was instructed on proper insertion procedure.Customer was also advised to monitor site as cannula may have broken off in site.No further 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.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.

• 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: 4422490
• MDR Text Key: 17220957
• Report Number: 2032227-2015-02162
• 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: 12/28/2014

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-7510
• Device Catalogue Number: MMT-7510
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/28/2014
• Initial Date FDA Received: 01/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 33 YR
• Patient Weight: 77