MAUDE Adverse Event Report: MEDTRONIC MINIMED SENSOR ENLITE; CGM

Model Number MMT-7008A

Device Problems Difficult to Insert (1316); Device Displays Incorrect Message (2591)

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

Event Date 05/08/2014

Event Type  malfunction  

Event Description

Customer called in to report their blood glucose sensor alarmed during insertion.Patient's blood glucose level was 126 mg/dl at time of reporting.During troubleshooting, the customer stated that they believe a portion of the cannula may have broken off and remained in their body.Advised customer to contact healthcare provider.Nothing further 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.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.

Manufacturer Narrative

Inspected one opened/used enlite sensor and performed bicarbonate buffer test.The sensor passed per specifications with accurate readings.No broken or missing parts anomalies were observed during analysis.

• Brand Name: SENSOR ENLITE
• 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: 3854927
• MDR Text Key: 4616986
• Report Number: 2032227-2014-02927
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• PMA/PMN Number: 120010
• 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: 05/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2014
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/08/2014
• 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 Age: 44 YR
• Patient Weight: 87