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U.S. Department of Health and Human Services

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

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MEDTRONIC MINIMED SENSOR ENLITE MMT-7008B ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND Back to Search Results
Model Number MMT-7008B
Device Problems False Reading From Device Non-Compliance (1228); Device Displays Incorrect Message (2591)
Patient Problem Hyperglycemia (1905)
Event Date 04/06/2018
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's mother reported via phone call the sensor had inaccurate readings that triggered threshold suspend alarm. The customer¿s blood glucose was 302 mg/dl and the sensor glucose was 105 mg/dl at the time of the incident. Details that led to the event and add relevant information if applicable. The customer was informed that their blood glucose and sensor glucose levels were not in acceptable range. The sensor will not be returned for analysis.
 
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Brand NameSENSOR ENLITE MMT-7008B
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 Key7463303
MDR Text Key106570730
Report Number2032227-2018-02735
Device Sequence Number1
Product Code OZO
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial
Report Date 04/25/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/25/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMMT-7008B
Device Catalogue NumberMMT-7008B
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/06/2018
Was Device Evaluated by Manufacturer? No Answer Provided
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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