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

Model Number MMT-751NAP

Device Problems Failure to Zero (1683); Improper or Incorrect Procedure or Method (2017)

Patient Problem Hyperglycemia (1905)

Event Date 06/01/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 via phone call that she has been having high blood glucose during the morning and believes that it is because her basal rates are set to zero at night.Reviewed her basal rates and they were not set to zero.The customer¿s pump was set to military time and she mixed the time with the basal rates.She said that she went to her doctor about three weeks prior and that they changed her basal rates and that she has been continually high in the morning ever since.Her blood glucose varied between 255 to 404 mg/dl.The customer declined troubleshooting for high blood glucose because she stated that she treated with the pump and manual injection.She was advised to monitor and to call back if any other issues came up.The insulin pump and the infusion set will not be returning for analysis.

• Brand Name: 530G INSULIN PUMP MMT-751NAP
• 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: 6669988
• MDR Text Key: 78480606
• Report Number: 2032227-2017-23831
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00643169503700
• UDI-Public: (01)00643169503700
• 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: 06/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-751NAP
• Device Catalogue Number: MMT-751NAP
• Device Lot Number: A4751NAPJ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/01/2017
• Initial Date FDA Received: 06/27/2017
• 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 Outcome(s): Other
• Patient Age: 60 YR
• Patient Weight: 216