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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MINIMED SENSOR; CGM
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MEDTRONIC MINIMED SENSOR; CGM Back to Search Results
Model Number 7005873-002
Device Problem Loss of Power (1475)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/21/2014
Event Type  malfunction  
Event Description
It was reported the customer's sensor failed to initialize.No additional information provided.
 
Manufacturer Narrative
Currently it is unknown whether or not the device may have caused or contributed to the event.The device has been returned, but not yet evaluated.Further information will follow once the analysis has been completed.No conclusion can be drawn at this time.
 
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Brand Name
SENSOR
Type of Device
CGM
Manufacturer (Section D)
MEDTRONIC MINIMED
18000 devonshire street
northridge CA 91325
Manufacturer (Section G)
MEDTRONIC MINIMED
18000 devonshire street
northridge CA 91325 121
Manufacturer Contact
christopher tupper
18000 devonshire street
northridge, CA 91325-1219
8185764313
MDR Report Key4269038
MDR Text Key21490703
Report Number2032227-2014-55599
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Other
Type of Report Initial
Report Date 10/23/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number7005873-002
Device Catalogue Number7005873-002
Device Lot NumberI234
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/17/2014
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 10/23/2014
Initial Date FDA Received11/21/2014
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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