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 Improper or Incorrect Procedure or Method (2017); Calibration Problem (2890)

Patient Problem Hypoglycemia (1912)

Event Date 10/02/2017

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.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 by the customer's parent that the customer received emergency medical assistance due to low blood glucose on (b)(6) 2017 with blood glucose of 28 mg/dl at the time of the incident.The customer was at 370 mg/dl at the time of the call.The customer was given a glucagon shot and intravenous fluids to treat.The customer was not wearing the insulin pump during the incident, within less than 48 hours.The customer stated that the pump gave them 60 units of insulin that was un-programmed.Troubleshooting was not completed as the customer declined.Customer was having sensor signal and calibration issues as well.The insulin pump will be returned for analysis.

Manufacturer Narrative

Findings: pump received with the operating currents within spec.And passed the self test, unexpected alarm error test, rewind, basic occlusion test, occlusion test, prime test, excessive no delivery test, displacement test, and the dat test.Pump was programmed with test minilink and the glucose sensor simulator.Pump communicated properly with glucose sensor simulator and displayed the programmed calibration blood glucose values, 100 mg/dl and 99 mg/dl properly on display graph.No weak signal alarms or sensor calibration errors noted.Pump was programmed with multiple boluses and monitored.All boluses delivered properly and were listed in the bolus history screen.Pump then was programmed with multiple basal profiles and monitored.All basal profiles delivered their indicated amounts and were verified in the daily total screen.The units left at pump display matched properly the units left at test reservoir.No delivery anomaly, bolus anomaly or basal anomaly noted during testing.Pump received with cracked reservoir tube lip, minor scratched lcd window, and scratched reservoir tube window.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.

• 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: 6950238
• MDR Text Key: 89341293
• Report Number: 2032227-2017-58743
• 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
• Type of Report: Initial,Followup
• Report Date: 10/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2017
• 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: 10/17/2017
• Date Manufacturer Received: 10/30/2017
• 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 Age: 16 YR
• Patient Weight: 126