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

Model Number MMT-554LCMS

Device Problems Insufficient Flow or Under Infusion (2182); Device Operates Differently Than Expected (2913); Electromagnetic Compatibility Problem (2927)

Patient Problem Hyperglycemia (1905)

Event Date 06/27/2017

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.(b)(4).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

It was reported via phone call that the customer was experiencing high blood glucose levels.Customer's blood glucose levels at the time of the incident was 252 mg/dl.Customer's current blood glucose was 380 mg/dl.Caller reported that the insulin pump is under delivering insulin.Caller reported that the insulin pump was worn during an mri.Caller also reported that they are unable to upload to carelink.Troubleshooting was done: the device settings were programmed accurately.Advised discontinuation of the insulin pump and revert to back up plan per health care professional.Product is not expected to return.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-554LCMS
• 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: 6725109
• MDR Text Key: 80560590
• Report Number: 2032227-2017-29729
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00643169533721
• UDI-Public: (01)00643169533721
• 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: 07/19/2017

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 Number: MMT-554LCMS
• Device Catalogue Number: MMT-554LCMS
• Device Lot Number: A1554LCMSJ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/28/2017
• Initial Date FDA Received: 07/19/2017
• 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