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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 Problem No Display/Image (1183)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/11/2017
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 the insulin pump had a blank display. Blood glucose level at the time of the incident was not provided. During troubleshooting, the display returned and the customer was able to program the device. The insulin pump was not replaced or 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 Key6622639
MDR Text Key77316764
Report Number2032227-2017-20860
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 06/08/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/08/2017
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 Received05/11/2017
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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