MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 630G INSULIN PUMP MMT-1715K 630G BLACK MG; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number MMT-1715K

Device Problem Failure to Deliver (2338)

Patient Problems Chest Pain (1776); Hyperglycemia (1905); Nausea (1970); Pain (1994); Respiratory Distress (2045); Diabetic Ketoacidosis (2364)

Event Date 06/19/2017

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¿s mother reported via phone call that her daughter was hospitalized for high blood glucose and diabetes ketoacidosis.She said that the customer was hospitalized for two days and released on the third.The caller stated that the insulin pump was not giving her daughter the insulin it was supposed to.The customer was nauseated, had difficulty breathing, had chest and back pains.The caller said that she treated with an insulin pen injection.The caller took the customer to the er on (b)(6) 2017 at 8:00 pm, with the blood glucose of 470 mg/dl.The customer was admitted and treated with fluids and medication through an iv.The doctor told her that the cause of the er visit/hospitalization was because of high blood glucose.The customer was wearing the pump at the time of the hospitalization.During troubleshooting for high blood glucose, the caller stated that the customer¿s doctor had recently made some programming changes to the insulin pump.She said there was no damage to tubing clamp.She was assisted with performing the high-pressure test and the pump passed.The customer was advised to change the infusion set, reservoir and insulin and to treat per her healthcare professional's recommendation.The insulin pump will not be returning for analysis.

• Brand Name: 630G INSULIN PUMP MMT-1715K 630G BLACK MG
• 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: 6734241
• MDR Text Key: 80747514
• Report Number: 2032227-2017-30542
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00643169656840
• UDI-Public: (01)00643169656840
• 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: 07/21/2017

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-1715K
• Device Catalogue Number: MMT-1715K
• Device Lot Number: HG1M15H
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/26/2017
• Initial Date FDA Received: 07/21/2017
• Date Device Manufactured: 01/23/2017
• 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): Hospitalization
• Patient Age: 14 YR