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

Model Number MMT-551NAS

Device Problems Component Falling (1105); No Display/Image (1183); Moisture Damage (1405)

Patient Problem Hyperglycemia (1905)

Event Date 07/26/2017

Event Type  malfunction  

Manufacturer Narrative

Unit received with blank display due to moisture damage electronic assembly.Moisture damage motor assembly.Unit had minor scratched lcd window, cracked case near display window corners, cracked battery tube threads and cracked reservoir tube lip.Unable to perform functional test due to blank display.

Event Description

Customer reported via phone call cosmetic damage.The customer's blood glucose was unknown at the time of call.Trouble shooting was performed and found screen darkens when customer presses act/esc button.Customer reported insulin pump exposed to moisture.The customer reported son dropped bag containing device into the lake.Advice to discontinue use of the insulin pump and revert to backup plan.Advised the device will need to be replaced.The insulin pump will be returned for analysis.

• Brand Name: 530G INSULIN PUMP MMT-551NAS
• 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: 7617994
• MDR Text Key: 111990432
• Report Number: 3004209178-2018-83309
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00643169503663
• UDI-Public: (01)00643169503663
• 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: 06/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-551NAS
• Device Catalogue Number: MMT-551NAS
• Device Lot Number: A4551NASJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/26/2017
• 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: 41 YR
• Patient Weight: 138