MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK; ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL

Model Number	MMT-1760KPK
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	12/25/2017
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Customer (primary investigator) reported for patient via phone call for high blood glucose.Blood glucose was 589 mg/dl.Customer had a device related adverse event with a diagnosis of severe hyperglycemia.Customer reported that event was moderate in nature and the subject recovered without sequele.Customer reported mom contacted cde and stated that she changed out cartridge and forgot to rewind it first and patient did not get any insulin for a large lunch and just realized missing basal also ,blood glucose was 589 mg/dl with blood ketones of 2.2 mmol.Customer reported that mom gave correction shot and within 3 hours blood glucose was 313 mg/dl and blood ketones were at 0.2 mmol.Customer reported that patient did not vomit or get sick.The pump will not be returned for analysis.
Additional Manufacturer Narrative
The device information provided with the initial report was incorrect.The correct information has been provided with this report.

• Brand Name: MMT-1780KPK
• Common Device Name: ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386
• MDR Report Key: 7166286
• Report Number: 3004209178-2018-40976
• Device Sequence Number: 1448044
• Product Code: OZP
• UDI-Device Identifier: 00643169946057
• UDI-Public: (01)00643169946057
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2018

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
• Operator of Device: Lay User/Patient
• Device Model Number: MMT-1760KPK
• Device Catalogue Number: MMT-1760KPK
• Device Lot Number: HG20YMW
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/25/2017
• Supplement Date Received by Manufacturer: 01/16/2018
• Initial Report FDA Received Date: 01/04/2018
• Supplement Report FDA Received Date: 01/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 79