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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MINIMED PARADIGM REAL-TIME INSULIN INFUSION PUMP; INSULIN INFUSION PUMP / SENSOR AUGMENTED

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MEDTRONIC MINIMED PARADIGM REAL-TIME INSULIN INFUSION PUMP; INSULIN INFUSION PUMP / SENSOR AUGMENTED Back to Search Results
Model Number MMT-754LCAB
Device Problems Device Displays Incorrect Message (2591); Electromagnetic Compatibility Problem (2927)
Patient Problem Hyperglycemia (1905)
Event Date 10/04/2013
Event Type  malfunction  
Manufacturer Narrative
The insulin pump alarmed motor error during rewind due to motor encoder signal out of phase.The displacement test could not be performed due to the motor error alarms.The device also had cracked reservoir tube lip and cracked case near display window corners.The insulin pump involved in this event is the paradigm real-time veo insulin infusion pump, which is not marketed in the united states.However, the device is similar to the paradigm real-time insulin infusion pump, which is marketed in the united states.Note: this is a remediation mdr.Medtronic diabetes implemented revised mdr reportability criteria effective on july 1, 2014.Subsequently, medtronic diabetes conducted a one year retrospective review of complaints.This event was retrospectively identified to be reportable based on the revised mdr reportability criteria.
 
Event Description
The customer's daughter reported via phone call that the pump had a motor error alarm.The blood glucose at the time of the incident was 11 mmol/l.It was stated that the device was exposed to a magnetic field as the customer wore it during an mri.Troubleshooting was not able to resolve the issue.The device was returned for analysis.
 
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Brand Name
PARADIGM REAL-TIME INSULIN INFUSION PUMP
Type of Device
INSULIN INFUSION PUMP / SENSOR AUGMENTED
Manufacturer (Section D)
MEDTRONIC MINIMED
18000 devonshire street
northridge CA 91325
Manufacturer (Section G)
MEDTRONIC MINIMED
18000 devonshire street
northridge CA 91325 1219
Manufacturer Contact
gerwin de graaff
18000 devonshire street
northridge, CA 91325-1219
8185764805
MDR Report Key5987688
MDR Text Key56347616
Report Number2032227-2016-22543
Device Sequence Number1
Product Code OYC
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
P980022
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial
Report Date 10/04/2013
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-754LCAB
Device Catalogue NumberMMT-754LCAB
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/18/2013
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 10/04/2013
Initial Date FDA Received09/29/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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