MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP MMT-751NAB; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number MMT-751NAB

Device Problems Improper or Incorrect Procedure or Method (2017); Device Displays Incorrect Message (2591)

Patient Problem Hyperglycemia (1905)

Event Date 03/06/2018

Event Type  malfunction  

Manufacturer Narrative

Currently it is unknown whether or not the device may have caused or contributed to the event.The device has been returned, but not yet evaluated.Further information will follow once the analysis has been completed.No conclusion can be drawn at this time.

Event Description

Customer reported via phone call that insulin pump alarmed for motor position encoder error.Customer stated that they experienced high blood glucose of 180mg/dl and customer¿s current blood glucose was 267mg/dl.Customer alleged possible insulin under delivery.Customer mentioned that the drive support cap appears normal.Customer stated that insulin pump was exposed to high magnetic field as they went through airport body scanner with pump.Customer advised to refer to back up plan.Insulin pump will be return for analysis.

Manufacturer Narrative

Device passed displacement test, self test, operating currents, off no power, unexpected restart error test, rewind, basic occlusion, occlusion, prime or compromised force sensor system alarm and excessive no delivery test.Device passed the delivery accuracy test.Motor passed motor test.No motor error alarm.Unable to confirm motor position encoder error alarm due to erased history file.Device received with minor scratched display window, cracked case at display window corner, cracked battery tube threads, cracked reservoir tube lip and stained address or serial number label.

• Brand Name: 530G INSULIN PUMP MMT-751NAB
• Type of Device: ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND
• 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: 7352267
• MDR Text Key: 103045270
• Report Number: 3004209178-2018-57979
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00643169503670
• UDI-Public: (01)00643169503670
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 06/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-751NAB
• Device Catalogue Number: MMT-751NAB
• Device Lot Number: A4751NABJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/18/2018
• 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
• Patient Age: 51 YR
• Patient Weight: 255