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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MINIMED OTHER

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MEDTRONIC MINIMED OTHER Back to Search Results
Model Number MMT-XXX
Device Problems Partial Blockage (1065); Low Battery (2584); Device Displays Incorrect Message (2591); Charging Problem (2892); No Flow (2991)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/16/2017
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
It was reported via phone call that customer¿s pump alarmed for insulin flow blocked and low battery after changing new battery timely in manner. Customer¿s blood glucose was unknown at time of incident. Customer states that internal source was unable to charge and notification light did not stops flashing immediately. Customer advised to monitor the pump and call back if issue persists. Insulin pump will not be returned for analysis.
 
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Brand NameOTHER
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 Key6911136
MDR Text Key88147510
Report Number2032227-2017-55202
Device Sequence Number1
Product Code LKK
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 10/03/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/03/2017
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 Received09/26/2017
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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