MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-754CML; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number MMT-754CML

Device Problem Mechanical Problem (1384)

Patient Problems Hyperglycemia (1905); Nausea (1970); Palpitations (2467)

Event Date 03/25/2020

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.(b)(4).

Event Description

Information received by medtronic indicated that the insulin pump had a motor error and no delivery alarm.The customer experienced high blood glucose ranged from 21.0 mmol/l to 25.4 mmol/l at the time of incident.The customer¿s blood glucose level was 25.4 mmol/l at the time of incident.The customer was treated with insulin pump.The customer did experienced the symptoms such as nausea and heart palpitations.The customer stated drive support cap was flush.Customer was using insulin pump system within 48 hours of reported high blood glucose event.The insulin pump will not be returned for analysis.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-754CML
• 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; * 00777-3869
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386; * 00777-3869
• Manufacturer Contact: gerwin de graaff ; ceiba norte ind. park #50 road; juncos 00777--386 ; * 00777-3869 ; 8185464805
• MDR Report Key: 9925238
• MDR Text Key: 186437794
• Report Number: 3004209178-2020-93974
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00643169528765
• UDI-Public: (01)00643169528765
• 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: 04/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-754CML
• Device Catalogue Number: MMT-754CML
• Device Lot Number: A7754CMLJ
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/25/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/18/2015
• 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