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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-522LCAL
Device Problems Device Displays Incorrect Message (2591); Electromagnetic Compatibility Problem (2927)
Patient Problem Hyperglycemia (1905)
Event Date 05/12/2014
Event Type  malfunction  
Manufacturer Narrative
Failure analysis noted that the pump passed the rewind, basic occlusion, and prime/ compromised force sensor and displacement tests.The pump was received stuck in motor error alarm loop during bolus delivery and motor position encoder error alarm confirmed in the history file.The motor was tested outside to the device and passed.The motor may have had an intermittent failure that was not detected during our testing.Pump received with cracked reservoir tube lip and cracked battery tube threads.Note: this is a remediation mdr.Medtronic diabetes implemented revised mdr reportability criteria effective on (b)(6) 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 reported via phone call that the pump had motor error alarm and motor position encoder error alarm.The blood glucose at the time of the incident was 7.0 mmol/l.The customer states the insulin pump was exposed to a high magnetic field, when they passed threw a body scanner.The customer stated there was a motor position encoder error alarm noted in the history.Troubleshooting was not able to resolve the issue.The customer was advised to disconnect from the insulin pump and revert to back-up plan.The customer was advised that the insulin pump will need to be replaced.The device will be 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 Key5987694
MDR Text Key56196444
Report Number2032227-2016-22483
Device Sequence Number1
Product Code OYC
Combination Product (y/n)N
Reporter Country CodeCA
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 05/12/2014
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-522LCAL
Device Catalogue NumberMMT-522LCAL
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/17/2014
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 05/12/2014
Initial Date FDA Received09/29/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2013
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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