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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 Problems Air Leak (1008); Bent (1059)
Patient Problem Hyperglycemia (1905)
Event Date 05/30/2017
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
The customer reported via phone call that they were experiencing high blood glucose levels and wanted to verify that the insulin pump was functioning properly. Blood glucose level at the time of the incident was 510 mg/dl. Blood glucose level at the time of the call was 355 mg/dl. Customer treated the high readings with insulin pen and insulin pump. The customer also reported getting air bubbles at the end of the tubing. During troubleshooting, the customer was able to remove the air bubbles. Customer was asked to change the infusion set. When customer removed the infusion set it had a bent cannula which may have caused for the high readings. Customer declined to continue to troubleshooting. Customer was advised to change entire set, reservoir and insulin and treat per healthcare provider's instructions. The insulin pump was not replaced or returned for analysis.
 
Manufacturer Narrative
The information provided was incorrect with the initial report. The correct information has been provided with this report. 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.
 
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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 Key6718783
MDR Text Key80203641
Report Number2032227-2017-29046
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 company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/20/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/17/2017
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 Received05/30/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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