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 Crack (1135); Improper or Incorrect Procedure or Method (2017); Moisture or Humidity Problem (2986)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/03/2017

Event Type  malfunction  

Manufacturer Narrative

The insulin pump had a blank display due to moisture damage on the electronics.There was also moisture damage found on the motor.The insulin pump had cracked case at display window corner, belt clip slot, reservoir tube lip and minor scratched display window.

Event Description

The customer's mother reported via phone call that the insulin pump was exposed to moisture.The customer¿s blood glucose was 190 mg/dl at the time of the incident.Mother states customer was at the ocean and the customer jumped in and now there is fluid under the display.The pump also has little crack where the reservoir goes in.The mother was advised to discontinue use of the insulin pump and to revert to the back-up plan.The insulin pump will 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: 6809068
• MDR Text Key: 83243801
• Report Number: 2032227-2017-38857
• 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
• Report Date: 08/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2017
• 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: A3751NASJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/03/2017
• 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: 44 YR
• Patient Weight: 108