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 Break (1069); Loose or Intermittent Connection (1371)

Patient Problems Death (1802); Hyperglycemia (1905); Diabetic Ketoacidosis (2364)

Event Date 04/23/2018

Event Type  Death  

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

It was reported that the customer passed away in hospital.The customer was hospitalized on (b)(6) 2018 due to high blood glucose, diabetic ketoacidosis, and a coma.The cause of death was a coma and diabetic ketoacidosis.The caller stated that the customer had no illnesses that may have led to the customer's passing.The customer¿s blood glucose was over 1500 mg/dl at the time of admission.The customer was not wearing the insulin pump at the time of death.The pump had been removed within less than 48 hours prior to passing, as the paramedics took off the pump.The customer was using sensors.The caller also reported that the customer had a high of over 600 on (b)(6) 2018 and they woke up vomiting, and later that day they noticed that the tubing that came out was broken and really loose like it had been cut.The caller declined to return the insulin pump for analysis or to upload the pump.

Manufacturer Narrative

A complete analysis and testing of the insulin pump showed that it was functioning properly and passed all functional testing.After testing it was concluded that the device operated within specifications.Unit was received with all operating currents within specification and passed functional testing including the rewind, basic occlusion test, occlusion test, prime/compromised force sensor system test, excessive no delivery test, self-test, unexpected restart error test and displacement test.Insulin pump passed the dat test at 0.08655 inches.

• 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: 7573281
• MDR Text Key: 110212242
• Report Number: 3004209178-2018-77974
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00643169503717
• UDI-Public: (01)00643169503717
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 08/02/2018

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-751NAS
• Device Catalogue Number: MMT-751NAS
• Device Lot Number: A4751NASJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2018
• Initial Date Manufacturer Received: 05/10/2018
• Initial Date FDA Received: 06/06/2018
• Supplement Dates Manufacturer Received: 07/11/2018
• Supplement Dates FDA Received: 08/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2016
• 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): Death
• Patient Age: 42 YR
• Patient Weight: 200