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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MINIMED OTHER SENSOR, GLUCOSE, INVASIVE

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MEDTRONIC MINIMED OTHER SENSOR, GLUCOSE, INVASIVE Back to Search Results
Model Number MMT-XXX
Device Problems Failure to Deliver (2338); Device Displays Incorrect Message (2591)
Patient Problem Hyperglycemia (1905)
Event Date 07/29/2017
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. No conclusion can be drawn at this time. We therefore consider this report complete to the best of our knowledge.
 
Event Description
The customer reported via phone call that they received no delivery alarm. The customer's blood glucose was 314 mg/dl at the time of incident. The customer reported that the no delivery alarm was resolved by changing reservoir. The reservoir will not be returned for analysis.
 
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Brand NameOTHER
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 Key6817139
MDR Text Key83729972
Report Number2032227-2017-40288
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 08/24/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/24/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMMT-XXX
Device Catalogue NumberMMT-XXX
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 Received07/29/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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