MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP MMT-551LNAS; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number MMT-551LNAS

Device Problems Crack (1135); Loose or Intermittent Connection (1371); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/31/2018

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.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.

Event Description

It was reported that the top of the insulin cartridge was cracked and the rubber washer was barely hanging on.The insulin pump had a crack in the reservoir window.A small crack near the battery cap as well.The motor sounded louder and grinds during rewind.The insulin pump may have alarmed motor error.Customer's blood glucose level was not reported.The device was not returned.

Manufacturer Narrative

Device received unable to perform the displacement, rewind, basic occlusion, occlusion, prime and excessive no delivery or verify motor error alarm due to complete broken reservoir tube lip and missing reservoir tube o-ring noted.No failed battery test noted.The p-cap not locks into the reservoir compartment properly due to completely broken reservoir tube lip noted.The motor was tested outside of the device and passed.

• Brand Name: 530G INSULIN PUMP MMT-551LNAS
• 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: 7640648
• MDR Text Key: 112558494
• Report Number: 3004209178-2018-85439
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00643169507739
• UDI-Public: (01)00643169507739
• 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: 02/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-551LNAS
• Device Catalogue Number: MMT-551LNAS
• Device Lot Number: A4551LNASJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/18/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2016
• 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: 39 YR
• Patient Weight: 190