MAUDE Adverse Event Report: MEDTRONIC MINIMED SENSOR ENLITE; OZO

Model Number MMT-7008A

Device Problems Excess Flow or Over-Infusion (1311); Device Remains Activated (1525)

Patient Problems Hypoglycemia (1912); Overdose (1988)

Event Date 08/07/2015

Event Type  Injury  

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.

Event Description

Customer reported via phone call, on (b)(6) 2015 the insulin pump didn't may any noise or signal that her blood glucose was lowering.Customer stated her blood glucose was 28 mg/dl and the sensor didn't trigger the threshold suspend feature on the device.Current blood glucose was 400 mg/dl.Troubleshooting for low blood glucose was performed.Customer stated she was admitted for medical treatment due to the low.She was also in a vehicular accident where she was the driver.Customer stated prior the issue customer was active all day, had supper, and she was at baseball game.She had the accident on her way home from the game.Customer was unsure what the cause of the low might have been.No troubleshooting was performed on the sensor.The sensor is not returning for analysis.

• Brand Name: SENSOR ENLITE
• Type of Device: OZO
• Manufacturer (Section D): MEDTRONIC MINIMED; 18000 devonshire street; northridge CA 91325
• Manufacturer (Section G): MEDTRONIC MINIMED; 18000 devonshire street; northridge CA 91325 1219
• Manufacturer Contact: gerwin de graaff ; 18000 devonshire street; northridge, CA 91325-1219 ; 8185764805
• MDR Report Key: 5041065
• MDR Text Key: 24520971
• Report Number: 2032227-2015-38005
• Device Sequence Number: 1
• Product Code: OZO
• 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
• Report Date: 08/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-7008A
• Device Catalogue Number: MMT-7008A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Hospitalization
• Patient Age: 65 YR
• Patient Weight: 73