MAUDE Adverse Event Report: MEDTRONIC MINIMED SENSOR ENLITE OZO

Model Number MMT-7008A

Device Problems Incorrect, Inadequate or Imprecise Resultor Readings (1535); Calibration Problem (2890)

Patient Problems Hyperglycemia (1905); Hypoglycemia (1912); Overdose (1988)

Event Date 08/30/2015

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

The customer reported via phone call that his sensor glucose was 51 mg/dl but his blood glucose was 450 mg/dl. The patient treated his high with an insulin pump bolus. The customer also mentioned that the difference in readings has caused him to overtreat for his blood glucose and experience hypoglycemic events as well. Troubleshooting was initiated for the disparity between the sensor glucose and blood glucose readings. The customer was assisted with properly calibrating the sensor and general sensor use. No products were returned and a replacement sensor was shipped to the customer.

• 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: 5088940
• MDR Text Key: 26227818
• Report Number: 2032227-2015-46399
• Device Sequence Number: 1
• Product Code: OZO
• Combination Product (Y/N): N
• 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: 08/30/2015

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 09/18/2015
• 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

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/30/2015
• 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: Unkown

Patient TREATMENT DATA

Date Received: 09/18/2015 Patient Sequence Number: 1