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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 False Reading From Device Non-Compliance (1228); Device Displays Incorrect Message (2591)
Patient Problem Hypoglycemia (1912)
Event Date 02/25/2018
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. 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
The customer reported via phone call that the customer¿s blood glucose was low and the sensor had inaccurate readings that triggered threshold suspend alarm. The customer¿s blood glucose was 143 mg/dl and the sensor glucose was 55mg/dl at the time of the incident. The customer reported that sensor glucose and blood glucose difference is not within acceptable range. Insulin delivery was suspended due to sensor glucose value of 52mg/dl. Low suspend limit in sensor settings was 70. Customers current blood glucose was 200mg/dl. Customer states the drive support cap appears normal. Based on customer report proceeding in troubleshooting the customer was alleging possible pump over delivery. The customer¿s blood glucose was 93mg/dl. Also sensor glucose was 135mg/dl when blood glucose 97mg/dl. The customer also reported sensor glucose value of 71mg/dl and then blood glucose 128mg/dl. Also blood glucose was 170mg/dl. The sensor will be returned for analysis. The insulin pump will not be returned for analysis.
 
Manufacturer Narrative
The information provided in concomitant reporting section with the initial report was incorrect. The correct information has been included with this report.
 
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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 Key7636861
MDR Text Key112275183
Report Number2032227-2018-07334
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 11/18/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/26/2018
Is this an Adverse Event Report? Yes
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 Manufacturer10/18/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/18/2018
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: 06/26/2018 Patient Sequence Number: 1
Treatment
MMT-551NAS
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