MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-554LCML; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number MMT-554LCML

Device Problems Fluid/Blood Leak (1250); Device Displays Incorrect Message (2591); Device Sensing Problem (2917)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/04/2018

Event Type  malfunction  

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.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.

Event Description

The customer reported via phone call that the insulin pump had a compromised force sensor system and motor error alarm.The customer¿s blood glucose level was unknown at the time of the incident.The customer also reported that the insulin was squirting during manual prime process.The customer stated that the drive support cap was normal.The customer was advised to discontinue use of the insulin pump and to revert to the backup plan.The insulin pump is being replaced and is not expected to return for analysis.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-554LCML
• Type of Device: PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386
• Manufacturer Contact: gerwin de graaff ; ceiba norte ind. park #50 road; juncos 00777--386
• MDR Report Key: 7604402
• MDR Text Key: 111658054
• Report Number: 3004209178-2018-81870
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00643169500181
• UDI-Public: (01)00643169500181
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-554LCML
• Device Catalogue Number: MMT-554LCML
• Device Lot Number: A0554LCMLJ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/04/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/06/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1