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

Model Number MMT-754WWS

Device Problems Erratic or Intermittent Display (1182); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/16/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 the insulin pump alarmed button error.The customer¿s blood glucose was 136 mg/dl at the time of incident.Customer stated that the insulin pump alarmed button error and the numbers were scrolling without the user's input.No significant event leading to button error or keypad anomaly were observed.Button error troubleshooting was performed and confirmed that time is not advancing even after the battery has been changed.The customer was advised to discontinue use of pump and revert to back-up plan.The insulin pump is being replaced and is expected to return for analysis.

Manufacturer Narrative

No frozen screen or button error alarm noted.The insulin pump's time/clock moved.The insulin pump had unresponsive act and up buttons due to corroded keypad traces.No unexpected numbers ramping/scrolling during testing.The insulin pump had minor scratched lcd window, cracked lcd window, cracked case at display window corners, cracked battery tube threads, cracked reservoir tube lip and broken belt clip slot.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-754WWS
• 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: 6774716
• MDR Text Key: 82875850
• Report Number: 2032227-2017-35166
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 00643169304741
• UDI-Public: (01)00643169304741
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/16/2017

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-754WWS
• Device Catalogue Number: MMT-754WWS
• Device Lot Number: B2754WWSJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2017
• Initial Date Manufacturer Received: 07/16/2017
• Initial Date FDA Received: 08/08/2017
• Supplement Dates Manufacturer Received: 10/09/2017
• Supplement Dates FDA Received: 10/16/2017
• 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