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

Model Number MMT-554CML

Device Problem Malposition of Device (2616)

Patient Problem Hyperglycemia (1905)

Event Date 05/07/2018

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 that the o ring on the reservoir compartment of the insulin pump was not correctly positioned.The customer¿s blood glucose level was 18 mmol/l.The insulin pump will not be returned for analysis.

Manufacturer Narrative

Device received with partially broken off reservoir tube lip.However the test reservoir was click or lock in place.Pump passed basic occlusion test, occlusion test, prime test, excessive no delivery test, displacement test and rewind test.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-554CML
• 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: 7497945
• MDR Text Key: 107742411
• Report Number: 3004209178-2018-70325
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00613994951434
• UDI-Public: (01)00613994951434
• 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: 08/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-554CML
• Device Catalogue Number: MMT-554CML
• Device Lot Number: A5554CMLJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/16/2018
• 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