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

Model Number MMT-554CMS

Device Problems Break (1069); Scratched Material (3020)

Patient Problem Hypoglycemia (1912)

Event Date 04/19/2018

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.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

It was reported damage to the insulin pump battery compartment and screen the customer¿s blood glucose was 2.6 mmol/l l at the time of incident.Customer stated that the insulin pump screen was scratched up and hard to see the display.Customer also reported damage to the battery compartment.Customer had a low blood glucose of 2.6 mmol/l and no form of treatment was reported.No low blood glucose troubleshooting was performed.The customer was advised that the insulin pump is being replaced and is not expected to return for analysis.

Manufacturer Narrative

Pump passed the displacement.Pump received with minor scratched lcd window and broken battery tube threads noted.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-554CMS
• 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: 7497905
• MDR Text Key: 107784751
• Report Number: 3004209178-2018-70319
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00643169503175
• UDI-Public: (01)00643169503175
• 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,Followup
• Report Date: 08/15/2018

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-554CMS
• Device Catalogue Number: MMT-554CMS
• Device Lot Number: A6554CMSJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/19/2018
• Initial Date FDA Received: 05/09/2018
• Supplement Dates Manufacturer Received: 07/17/2018
• Supplement Dates FDA Received: 08/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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