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

Model Number	MMT-751NAL
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hyperglycemia (1905); Elevated ketones/Diabetic Ketoacidosis (2364)
Date of Event	09/17/2018
Type of Reportable Event	Serious Injury
Additional 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.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.
Event or Problem Description
It was reported via phone call that the customer was hospitalized at an unknown time due to a high blood glucose exceeding 600 mg/dl.The patient was treated in the intensive care unit with intravenous fluids.The customer was wearing the insulin pump system within 48 hours of the hospitalization.The customer had a bent infusion set cannula at the time.Troubleshooting was declined for the high blood glucose.The insulin pump was not returned for analysis.

• Brand Name: 530G INSULIN PUMP MMT-751NAL
• Common Device Name: ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386
• MDR Report Key: 7921514
• Report Number: 2032227-2018-35376
• Device Sequence Number: 1653593
• Product Code: OZO
• UDI-Device Identifier: 00643169736085
• UDI-Public: (01)00643169736085
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/30/2018

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-751NAL
• Device Catalogue Number: MMT-751NAL
• Device Lot Number: A6751NALJ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2018
• Initial Report FDA Received Date: 10/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FRN RESUNOMED INFSET
• Outcome Attributed to Adverse Event: Hospitalization