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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 Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problems Bruise/Contusion (1754); Hyperglycemia (1905); No Consequences Or Impact To Patient (2199); Blood Loss (2597)
Event Date 08/14/2017
Event Type  malfunction  
Manufacturer Narrative
Inspected one opened/used partial sensor and performed continuity resistance test found sensor passed per specifications and performed the sensor initialization test using a new lab transmitter with a paradigm pump. Connected the sensor to the transmitter and placed it in 100 bts solution, confirmed the communication icon was displayed and that the transmitter was flashing while connected to the sensor. Unable to confirm insertion anomaly due to customer did not return insertion needle only sensor. The sensor functioned properly. Cannot performed bts test as the sensor is beyond its expiration date.
 
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. The device will be returned for analysis and further information will follow once the analysis has been completed. No conclusion can be drawn at this time.
 
Event Description
Customer called to report issues with sensor glucose verses blood glucose differences. Customer stated that the insulin pump alarmed threshold suspend. Customer's blood glucose reading was 230 mg/dl, while the sensor glucose was 125 mg/dl. Insulin delivery was suspended due to sensor glucose values. Sensor glucose value that triggered the suspend event was 68 mg/dl. Customer stated that the threshold suspend alarm was set at 75 mg/dl. Therefore, sensor glucose and blood glucose difference was not within acceptable range. Troubleshooting was done. Product is expected to return.
 
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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 Key6836432
MDR Text Key107567444
Report Number2032227-2017-43484
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 05/07/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/31/2017
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 Manufacturer09/28/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/25/2018
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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