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 Problems No Display/Image (1183); Loss of Power (1475); Device Operates Differently Than Expected (2913)

Patient Problem Hyperglycemia (1905)

Event Date 05/21/2018

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

The customer reported via phone call that they had blank display and failed battery.The customer¿s blood glucose level was 257 mg/dl.The customer was treated with manual injection for high blood glucose.The customer reported that they had issues with the insulin pump goes blank and it goes completely off and changed the battery reset everything with date and time and it came back, but it stays on a little bit and goes back off.It was reported that they had failed battery.The customer troubleshooting was performed and customer was advised to insert new aa battery and the display did return after pump restart.The customer declined to troubleshoot for high blood glucose and failed battery alarm read off little note off troubleshooting matrix for her declining.The customer was advised the customer to monitor the pump.The insulin pump will not be returned for analysis.

• 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: 7609557
• MDR Text Key: 111766030
• Report Number: 3004209178-2018-82640
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00643169736108
• UDI-Public: (01)00643169736108
• 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
• Report Date: 06/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2018
• 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: A6751NASJ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/22/2018
• Date Device Manufactured: 06/21/2017
• 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: 63 YR
• Patient Weight: 77