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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MINIMED SENSOR; MDS
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MEDTRONIC MINIMED SENSOR; MDS Back to Search Results
Model Number MMT-7002C
Device Problems Loss of Power (1475); Self-Activation or Keying (1557); Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/04/2014
Event Type  malfunction  
Event Description
It was reported that the customer received a signal too low alarm.It was also reported that it was shut down after observation.No additional info was provided.
 
Manufacturer Narrative
Currently it is unk 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.
 
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Brand Name
SENSOR
Type of Device
MDS
Manufacturer (Section D)
MEDTRONIC MINIMED
18000 devonshire st.
northridge CA 91325
Manufacturer (Section G)
MEDTRONIC MINIMED
18000 devonshire st.
northridge CA 91325
Manufacturer Contact
gerwin de graaff, dir
18000 devonshire st.
northridge, CA 91325-1219
8185764805
MDR Report Key4381244
MDR Text Key15114426
Report Number2032227-2014-67707
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
P980022
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 11/17/2014
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 NumberMMT-7002C
Device Catalogue NumberMMT-7002C
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 11/17/2014
Initial Date FDA Received12/17/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Unknown
Patient Sequence Number1
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