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

Model Number MMT-751NAS

Device Problem Fluid/Blood Leak (1250)

Patient Problem Hyperglycemia (1905)

Event Date 01/02/2018

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.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.

Event Description

The customer reported via phone call that the insulin pump alarmed unexpected restart.The customer reported that when they replace the battery it will come up with a blank screen and it will say 12 am.This time it was coming up the battery full, the insulin was empty and it's coming up unexpected restart.Customer stated this was the fourth time she had an issue when she changed the battery.Customer stated she does not know what her blood glucose was at the time.Customer stated she got home and could smell insulin leaking.Customer stated she checked her blood glucose at the time and it was 250mg/dl.Customer stated noticed the insulin leaking at her infusion site.Customer states a temp basal was not programmed before the unexpected restart alarm occurred.Alarm occurred shortly after inserting a new battery.The customer declined to troubleshoot for high blood glucose.Customer bolused with her pump to treat for high blood glucose.The customer was advised that the insulin pump needed to be replaced.The insulin pump will be returned for analysis.

Manufacturer Narrative

Pump passed the displacement, self test and no unexpected restart error alarm noted during test.Pump received with cracked case at the display window corner, broken reservoir tube lip, minor scratched lcd window, stained end cap sticker, stained address/serial number label, cracked belt clip slot, cracked case reservoir tube window corner, cracked lcd window and cracked battery tube threads.

• Brand Name: 530G INSULIN PUMP MMT-751NAS
• 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: 7186970
• MDR Text Key: 97668817
• Report Number: 3004209178-2018-43061
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00643169404342
• UDI-Public: (01)00643169404342
• 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: 05/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-751NAS
• Device Catalogue Number: MMT-751NAS
• Device Lot Number: A2751NASJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/27/2018
• 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: 64 YR
• Patient Weight: 195