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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MINIMED SENSOR ENLITE MMT-7008A ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

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MEDTRONIC MINIMED SENSOR ENLITE MMT-7008A ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND Back to Search Results
Model Number MMT-7008A
Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)
Patient Problem Hyperglycemia (1905)
Event Date 01/30/2018
Event Type  Injury  
Manufacturer Narrative

Inspected 1 opened/used sensor and performed continuity resistance test (b)(4). Sensor passed per specification. Also, performed bicarbonate buffer test. Sensor passed per specifications with accurate readings. See attached file for details.

 
Event Description

The customer reported via phone call that the blood glucose was high. The customer reported that he had sensor malfunctioned again. The customer reported that it lasts for 4 days. He did insulin for breakfast, it was showing that it was going low. He ate some bars. Pump was suspending insulin and his blood glucose was 480mg/dl. He had several sensor failures, he got it going he had sensor error, he waited for an hour and still not accepted, and started working for few hours but later it was not working still. The customer declined to troubleshoot for high blood glucose. The insulin pump will not be returned for analysis.

 
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Brand NameSENSOR ENLITE MMT-7008A
Type of DeviceARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND
Manufacturer (Section D)
MEDTRONIC MINIMED
18000 devonshire st.
northridge CA 91325 1219
Manufacturer (Section G)
MEDTRONIC MINIMED
18000 devonshire st.
northridge CA 91325 1219
Manufacturer Contact
gerwin de graaff
18000 devonshire st.
northridge, CA 91325-1219
MDR Report Key7628581
MDR Text Key111981389
Report Number2032227-2018-06978
Device Sequence Number1
Product Code OZO
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation PATIENT
Type of Report Initial
Report Date 06/22/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/22/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberMMT-7008A
Device Catalogue NumberMMT-7008A
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/21/2018
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/30/2018
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: 06/22/2018 Patient Sequence Number: 1
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