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Paradigm Insulin Pumps and Paradigm Insulin Infusion Pump (2014-03-17)

Starting date:
March 17, 2014
Posting date:
April 14, 2014
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-39013

Recalled Products

A. Paradigm 522 Insulin Pump
B. Paradigm 722 Insulin Pump
C. Paradigm Insulin Infusion Pump
D. Paradigm 554 Insulin Pump
E. Paradigm 754 Insulin Pump

Reason

Purpose of this notification is to reinforce important information regarding the safe use of Medtronic insulin pumps. Medtronic has received a small number of reports regarding users who have unintentionally programmed the pump to deliver the maximum bolus amount, including one incident that resulted in severe hypoglycemia. The inadvertent selection and delivery of a bolus amount that exceeds the amount intended by the user can result in hypoglycemia.

Medtronic is notifying all Paradigm pump users Healthcare professionals and certified pump trainers of the function of the wrap around scrolling feature and make them aware of the potential for user error.

Affected products

A. Paradigm 522 Insulin Pump
 

Lot or serial number

All lots

Model or catalog number

MMT-522
 

Companies
Manufacturer
Medtronic Minimed
18000 Devonshire St.
Northridge
91325
California
UNITED STATES

B. Paradigm 722 Insulin Pump
 

Lot or serial number

All lots

Model or catalog number

MMT-722
 

Companies
Manufacturer
Medtronic Minimed
18000 Devonshire St.
Northridge
91325
California
UNITED STATES

C. Paradigm Insulin Infusion Pump
 

Lot or serial number

All lots

Model or catalog number

MMT-511
MMT-512
MMT-515
MMT-712
MMT-715
 

Companies
Manufacturer
Medtronic Minimed
18000 Devonshire St.
Northridge
91325
California
UNITED STATES

D. Paradigm 554 Insulin Pump
 

Lot or serial number

All lots

Model or catalog number

MMT-554
 

Companies
Manufacturer
Medtronic Minimed
18000 Devonshire St.
Northridge
91325
California
UNITED STATES

E. Paradigm 754 Insulin Pump

Lot or serial number

All lots

Model or catalog number

MMT-754

Companies
Manufacturer
Medtronic Minimed
18000 Devonshire St.
Northridge
91325
California
UNITED STATES