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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 Bent (1059); False Reading From Device Non-Compliance (1228); Device Displays Incorrect Message (2591)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/10/2017
Event Type  malfunction  
Manufacturer Narrative
Currently it is unknown whether or not the device may have caused or contributed to the event. The device has been returned, but not yet evaluated. Further information will follow once the analysis has been completed. No conclusion can be drawn at this time.
 
Event Description
The customer reported via phone call the sensor had inaccurate readings that triggered threshold suspend alarm. The customer¿s blood glucose was 126 mg/dl and the sensor glucose was 70mg/dl at the time of the incident. Customer reported that he is having issue with needle breaking skin and called about that in the past. Sensor glucose and blood glucose difference was not within acceptable range. Insulin delivery was suspended due to sensor glucose value of 70 mg/dl. Threshold suspend limit in sensor settings was 58 mg/dl. The sensor cannula was also bent. The sensor will be returned for analysis.
 
Manufacturer Narrative
Inspected one opened/used sensor and found sensor retracted inside sensor. Unable to confirm customer received sensor damage due to customer returned opened/used.
 
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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 Key7270195
MDR Text Key100139559
Report Number2032227-2018-01480
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,Followup
Report Date 03/30/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/14/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMMT-7008A
Device Catalogue NumberMMT-7008A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/01/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/14/2018
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

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