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

Model Number	MMT-751NAH
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Hyperglycemia (1905); Nausea (1970); Elevated ketones/Diabetic Ketoacidosis (2364)
Date of Event	02/10/2019
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.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 or Problem Description
The customer¿s mother reported via phone call that they were went to emergency room due to high blood glucose and diabetic ketoacidosis on (b)(6) 2019 with blood glucose of 690 mg/dl.The customer's current blood glucose is 127 mg/dl.Customer has been using insulin pump system within 48 hours of reported high blood glucose event.The customer experienced nausea as a result of high blood glucose value.The customer treated high blood glucose value with intravenous manual injection.The customer reported small bubble.The connector of the insulin pump there was leaking coming out.Customer was unable to complete carelink upload.The drive support cap appears normal.The insulin pump will not be returned for analysis.

• Brand Name: 530G INSULIN PUMP MMT-751NAH
• 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: 8346879
• Report Number: 3004209178-2019-56698
• Device Sequence Number: 19313718
• Product Code: OZO
• UDI-Device Identifier: 00643169736078
• UDI-Public: (01)00643169736078
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/18/2019

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-751NAH
• Device Catalogue Number: MMT-751NAH
• Device Lot Number: A6751NAHJ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2019
• Initial Report FDA Received Date: 02/18/2019
• 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: Hospitalization
• Patient Age: 25 YR
• Patient Weight: 135