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

Model Number MMT-751NAL

Device Problem No Display/Image (1183)

Patient Problems Death (1802); Multiple Organ Failure (3261); Cancer (3262)

Event Date 08/17/2017

Event Type  Death  

Manufacturer Narrative

(b)(4).Pump received with blank display.Unable to determine root cause due to pump preservation.Unable to perform all functional tests, including the idle current measurement test, run current measurement test, self test, off no power test, a21 error test, displacement test, basic occlusion test, occlusion test, prime/a33 test, rewind test and excessive no delivery test due to blank display.Pump received with (b)(4) alkaline battery.Pump received with cracked case at the display window corner, cracked reservoir tube lip, cracked battery tube threads, scratched reservoir tube window and minor scratched lcd window.

Event Description

It was reported that the customer passed away at home.The cause of death was colon cancer and multiple organ failure.The caller stated that the customer had congestive heart failure that may have led to the customer's passing.The customer¿s blood glucose was unknown at the time of death.The customer was not wearing the insulin pump at the time of death.The pump had been disconnected more than 2 days prior to passing when the customer was hospitalized.The customer was not using sensors.The caller agreed to return the insulin pump for analysis.The pump was received with a blank display.

Manufacturer Narrative

Initial report or supplemental report had the incorrect aware date.The correct aware date is (b)(4) 2017.

• Brand Name: 530G INSULIN PUMP MMT-751NAL
• 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: 7087700
• MDR Text Key: 93878216
• Report Number: 2032227-2017-70566
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00643169503694
• UDI-Public: (01)00643169503694
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 02/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-751NAL
• Device Catalogue Number: MMT-751NAL
• Device Lot Number: A4751NALJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2017
• Date Manufacturer Received: 02/13/2019
• 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 Outcome(s): Death
• Patient Age: 62 YR