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

Model Number MMT-754LCMB

Device Problem Air Leak (1008)

Patient Problem Hyperglycemia (1905)

Event Date 04/25/2018

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.The device will be returned for analysis and further information will follow once the analysis has been completed.No conclusion can be drawn at this time.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 insulin pump had under delivery.The blood glucose level was 17mmol/l at the time of incident.The current blood glucose was 9mmol/l.Customer treated with insulin pump.Customer was assisted with troubleshooting.Insulin pump passed displacement test.Customer reported that drive support cap was normal.Customer was assisted with high pressure test and found that bubbles were in the tubing.Customer alleging the insulin pump because customer was experiencing unexplained high blood glucose.The product will not be return for the analysis.

Manufacturer Narrative

The device alarmed motor error during rewind due to motor encoder signal out of phase.Unable to perform self test, off no power test, unexpected restart error test, occlusion test, prime test, excessive no delivery test, displacement test, displacement accuracy test and bolus wizard test due to motor error alarm.Pump passed idle current test and run current test.Unable to verify under delivery bolus anomaly due to motor error alarm.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-754LCMB
• 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: 7599730
• MDR Text Key: 111448552
• Report Number: 3004209178-2018-81109
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00643169533738
• UDI-Public: (01)00643169533738
• 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: 08/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-754LCMB
• Device Catalogue Number: MMT-754LCMB
• Device Lot Number: A1754LCMBJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2016
• 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