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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED

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MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED Back to Search Results
Model Number MMT-754CAS
Device Problem Electromagnetic Interference (1194)
Patient Problem Hypoglycemia (1912)
Event Date 07/13/2015
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. The device will be returned for analysis and further information will follow once the analysis has been completed. No conclusion can be drawn at this time. 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.
 
Manufacturer Narrative
A complete analysis and testing of the insulin pump showed that it was functioning properly and passed all functional testing.  after testing, it was concluded that the device operated within specifications.  .
 
Event Description
The customer reported via phone call indicating that she was hospitalized due to low blood glucose. Customer's blood glucose was 1. 6 mmol/l. The customer was already in the hospital and being treated for a pickline. Customer stated the perceived cause of low blood glucose was unknown. The customer stated that the insulin pump exposed to ct scan. The customer was advised that the device would be replaced.
 
Manufacturer Narrative
The pump passed the delivery accuracy test and motor test.
 
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Brand NamePARADIGM REAL-TIME INSULIN INFUSION PUMP
Type of DeviceINSULIN INFUSION PUMP / SENSOR AUGMENTED
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
ceiba norte ind. park #50
road 31 km 24.4
juncos PR 00777 3869
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
ceiba norte ind. park #50
road 31 km 24.4
juncos PR 00777 3869
Manufacturer Contact
christopher tupper
18000 devonshire street
northridge, CA 91325-1219
8185764313
MDR Report Key4946258
MDR Text Key13969300
Report Number3004209178-2015-78173
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 Foreign,Company Representative,company representative
Reporter Occupation Patient
Type of Report Initial,Followup,Followup
Report Date 02/07/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/28/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMMT-754CAS
Device Catalogue NumberMMT-754CAS
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/07/2015
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/07/2017
Was Device Evaluated by Manufacturer? Yes
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: 07/28/2015 Patient Sequence Number: 1
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