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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MINIMED SENSOR MMT-7002 EA GLUCOSE EN SENSOR, GLUCOSE, INVASIVE

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MEDTRONIC MINIMED SENSOR MMT-7002 EA GLUCOSE EN SENSOR, GLUCOSE, INVASIVE Back to Search Results
Model Number MMT-7002
Device Problems False Reading From Device Non-Compliance (1228); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/08/2017
Event Type  malfunction  
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 the sensor had inaccurate readings that triggered threshold suspend alarm. The customer¿s blood glucose was 80mg/dl and the sensor glucose was 40mg/dl at the time of the incident. The customer was informed that their blood glucose and sensor glucose levels were not in acceptable range. The sensor will be returned for analysis.
 
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Brand NameSENSOR MMT-7002 EA GLUCOSE EN
Type of DeviceSENSOR, GLUCOSE, INVASIVE
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 Key6620099
MDR Text Key76959765
Report Number2032227-2017-20799
Device Sequence Number1
Product Code MDS
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 06/07/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/07/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMMT-7002
Device Catalogue NumberMMT-7002
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/09/2017
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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