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

Model Number MMT-751LNAS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Hyperglycemia (1905); Hypoglycemia (1912); Seizures (2063); Coma (2417)

Event Date 12/23/2017

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.The device will be returned for analysis and further information will follow once the analysis has been completed.No conclusion can be drawn at this time.

Event Description

It was reported that the customer passed away in hospital.The customer was hospitalized on (b)(6) 2017 due to low blood glucose.The cause of death was natural causes.The caller stated that the customer had no illnesses that may have led to the customer's passing.The customer¿s blood glucose was 20 mg/dl at the time of admission.The customer was wearing the insulin pump at the time of death.One week prior to admission, the customer was at 20 mg/dl that led to a hypoglycemic type coma and seizures.At the hospital, the customer was given glucose and went up to 300 mg/dl.Usually the customer took of their pump when they went to bed, but on that day they did not.The caller declined to provide further details or contact.The customer was not using sensors.The caller agreed to return the insulin pump for analysis.

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.Insulin pump passed all functional tests, including the idle current measurement test, run current measurement test, self-test, off no power test, unexpected restart error test, displacement test, basic occlusion test, occlusion test, prime/compromised force sensor system test, rewind test, excessive no delivery test and dat at 0.08750 inches.Insulin pump was received with alkaline battery.Insulin pump was received with cracked reservoir tube lip, cracked belt clip slot, scratched case and minor scratched lcd window.

• Brand Name: 530G INSULIN PUMP MMT-751LNAS
• 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: 7204006
• MDR Text Key: 97705355
• Report Number: 3004209178-2018-44380
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00643169507784
• UDI-Public: (01)00643169507784
• 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: 03/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-751LNAS
• Device Catalogue Number: MMT-751LNAS
• Device Lot Number: A4751LNASJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2018
• Date Manufacturer Received: 02/26/2018
• 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: 78 YR
• Patient Weight: 179