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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MINIMED 530G INSULIN PUMP MMT-751NAB ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

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MEDTRONIC MINIMED 530G INSULIN PUMP MMT-751NAB ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND Back to Search Results
Model Number MMT-751NAB
Device Problems Improper or Incorrect Procedure or Method (2017); High Readings (2459); Low Readings (2460)
Patient Problem Hypoglycemia (1912)
Event Date 10/09/2017
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 the they had accidentally yanked out the infusion set while they were sleeping. The customer¿s blood glucose during the incident was 130 mg/dl. The customer also had a low blood glucose of 41 mg/dl. They did not mention any form of treatment for the low blood glucose. They were unable to troubleshoot because they were driving at the time of the call. The insulin pump will not be returned for analysis.
 
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Brand Name530G INSULIN PUMP MMT-751NAB
Type of DeviceARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND
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 Key7005169
MDR Text Key91183993
Report Number2032227-2017-64179
Device Sequence Number1
Product Code OZO
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 11/06/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/06/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMMT-751NAB
Device Catalogue NumberMMT-751NAB
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 Received10/09/2017
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: 11/06/2017 Patient Sequence Number: 1
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