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

Model Number MMT-751NAL

Device Problems Air Leak (1008); No Display/Image (1183); Improper or Incorrect Procedure or Method (2017); Moisture or Humidity Problem (2986)

Patient Problem Hyperglycemia (1905)

Event Date 05/19/2018

Event Type  Injury  

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

The customer reported via phone call that the insulin pump screen was blank at morning and bubbles outside the reservoir.Customer's blood glucose level was high and it was 300 mg/dl.Customer reported that the insulin pump was exposed to moisture.The customer was advised that the insulin pump needed to be replaced and was advised to discontinue use of the insulin pump and to revert to the backup plan.Insulin pump will be returned for analysis.

Manufacturer Narrative

The insulin pump passed displacement test, self test, off no power test and all operating currents tested within the specification range.The insulin pump was monitored and tested with no blank display noted.The insulin pump was received with corroded battery tube noted.No moisture damage on electronics and motor assembly noted.

• Brand Name: 530G INSULIN PUMP MMT-751NAL
• 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: 7604522
• MDR Text Key: 111541353
• Report Number: 3004209178-2018-81937
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00643169503694
• UDI-Public: (01)00643169503694
• 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: 08/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-751NAL
• Device Catalogue Number: MMT-751NAL
• Device Lot Number: A4751NALJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2018
• 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: 03/10/2016
• 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
• Patient Age: 47 YR
• Patient Weight: 210