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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MINIMED INSULIN PUMP SENSOR, GLUCOSE, INVASIVE

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MEDTRONIC MINIMED INSULIN PUMP SENSOR, GLUCOSE, INVASIVE Back to Search Results
Model Number MMT-XXX
Device Problem Failure to Deliver (2338)
Patient Problem Hyperglycemia (1905)
Event Date 05/26/2017
Event Type  Injury  
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
Customer reported via phone call of a past event.  customer indicated that they were hospitalized sometime in 2013 due to high blood glucose of an unknown level.  the customer was queasy and had chest discomfort and was treated with iv fluids. The customer stated that she kept treating herself without the device saying no delivery. Customer's blood glucose then went low and would not register on the meter. Customer declined troubleshooting for high blood glucose. The product will not be returned for analysis.
 
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Brand NameINSULIN PUMP
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 Key6619332
MDR Text Key76897230
Report Number2032227-2017-20785
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 06/07/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/07/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
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 Received05/26/2017
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

Patient Treatment Data
Date Received: 06/07/2017 Patient Sequence Number: 1
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