MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME INSULIN INFUSION PUMP; INSULIN INFUSION PUMP / SENSOR AUGMENTED

Model Number MMT-754WWB

Device Problems Intermittent Continuity (1121); Device Displays Incorrect Message (2591)

Patient Problem Hyperglycemia (1905)

Event Date 08/10/2016

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.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

The customer reported via phone call indicating that they had excessive no delivery alarm.Customer's blood glucose at time of incident was 23.0mmol/l.Customer does not trust the pump and stated that it stops working from time to time resulting in high blood glucose.Customer would like the pump replaced.Customer advised to return the pump and we will replace it.

Manufacturer Narrative

The pump passed the displacement, self test, off no power, unexpected restart, rewind and basic occlusion tests.The pump was unable to prime during the prime test due to moisture damage on the force sensor resistor.Unable to perform the occlusion or excessive no delivery tests due to the prime/fill anomaly.Unable to confirm the no excessive no delivery alarms due to the prime/fill anomaly.All operating currents were within specification.The pump was received with a cracked reservoir tube lip, minor scratches on the display window, a cracked case at the display window corner, cracked battery tube threads and a cracked display window.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP
• Type of Device: INSULIN INFUSION PUMP / SENSOR AUGMENTED
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50; road 31 km 24.4; juncos PR 00777 3869
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50; road 31 km 24.4; juncos PR 00777 3869
• Manufacturer Contact: gerwin de graaff ; 18000 devonshire street; northridge, CA 91325-1219 ; 8185764805
• MDR Report Key: 5925836
• MDR Text Key: 54526615
• Report Number: 3004209178-2016-75102
• Device Sequence Number: 1
• Product Code: OYC
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: P980022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 09/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-754WWB
• Device Catalogue Number: MMT-754WWB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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