MAUDE Adverse Event Report: MEDTRONIC MINIMED SENSOR; CGM

Model Number MMT-7002C

Device Problems Calibration Error (1078); High Test Results (2457); Application Program Problem (2880); Device Sensing Problem (2917)

Patient Problem Hypoglycemia (1912)

Event Date 07/07/2014

Event Type  malfunction  

Event Description

Customer reports to have experienced blood glucose versus sensor glucose differences with threshold suspend when blood glucose were not low.Customer states sensor glucose was 190 and blood glucose was 89 mg/dl.Customer also received calibration error, bad sensor and not able to upload to carelink.After troubleshooting, customer was advised to call back should issues persist and to monitor issue.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: 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 121
• Manufacturer Contact: christopher tupper ; 18000 devonshire street; northridge, CA 91325-1219 ; 8185764313
• MDR Report Key: 4606863
• MDR Text Key: 5630597
• Report Number: 2032227-2015-09998
• 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: 07/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2015
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/07/2014
• 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: 56 YR
• Patient Weight: 73