MAUDE Adverse Event Report: MEDTRONIC MINIMED SENSOR ENLITE; OZO

Model Number MMT-7008A

Device Problems Calibration Error (1078); Incorrect Or Inadequate Test Results (2456); Device Sensing Problem (2917)

Patient Problems Hyperglycemia (1905); Sleep Dysfunction (2517)

Event Date 06/02/2015

Event Type  malfunction  

Event Description

It was reported that the customer had differences between sensor glucose and blood glucose readings.Customer stated that he had issues with 3 out of 4 sensors he has used.Customer stated that a new sensor suspended thinking his blood glucose was 3 mmol/l but it was actually 9 mmol/l.Customer stated that he got up and realized what had happened.Customer received calibration errors for several hours, which caused him to have a major lack of sleep.Customer gave 3 glucose tabs without testing when his sensor headed downwards around midnight.Customer's blood glucose was actually 10 mmol/l so he had to quickly bolus for the glucose.Customer ended up fighting a 17 mmol/l and was not getting sleep.Customer stated that the first 24 hours and the last 24 hours of the sensor can be erratic.

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 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 121
• Manufacturer Contact: christopher tupper ; 18000 devonshire street; northridge, CA 91325-1219 ; 8185764313
• MDR Report Key: 4857401
• MDR Text Key: 20719846
• Report Number: 2032227-2015-19692
• Device Sequence Number: 1
• Product Code: OZO
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: 120010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2015
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/02/2015
• 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