MAUDE Adverse Event Report: MEDTRONIC MINIMED SENSOR ENLITE; OZO

Model Number MMT-7008A

Device Problems Excess Flow or Over-Infusion (1311); Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Displays Incorrect Message (2591)

Patient Problems Hyperglycemia (1905); Overdose (1988)

Event Date 11/18/2015

Event Type  malfunction  

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's mother reported via phone call that the sensors incorrectly alarmed high and low blood glucose levels.Sensor alarmed a 309 mg/dl blood glucose and the insulin pump delivered a correction insulin and caused the customer's blood glucose to drop to 72 mg/dl.Customer's mother reported the sensor triggered the threshold suspend when the customer's blood glucose was 136 mg/d, 122 mg/d, 140 mg/dl.Sensor glucose was 302 mg/dl when the customer's blood glucose was 202 mg/dl.After troubleshooting, customer was advised to monitor the issue.Customer will not be returning the sensors 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: 5277837
• MDR Text Key: 33478441
• Report Number: 2032227-2015-72636
• 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: other
• Type of Report: Initial
• Report Date: 11/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2015
• 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
• Device Lot Number: HG0PSZC
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/19/2015
• 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 Age: 6 YR
• Patient Weight: 24