MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. KIT MMT-1755KR 630G 3ML V4.10 EN RECERT; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number	MMT-1755KR
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	04/30/2019
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.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 reported via phone call that they experienced high blood glucose level of 400 mg/dl.Customer¿s current blood glucose level was 326 mg/dl.Customer had symptoms such as nausea, difficulty breathing.Customer reports that insulin exited with quick release.Customer did not allege for under delivering.Customer stated that there was no air bubble and leak.Customer was treated with insulin pump.Customer declined troubleshoot for high blood glucose level.The insulin pump will not be returned for analysis.

• Brand Name: KIT MMT-1755KR 630G 3ML V4.10 EN RECERT
• 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: 8581340
• Report Number: 3004209178-2019-93309
• Device Sequence Number: 1857586
• Product Code: OZO
• UDI-Device Identifier: 00763000179632
• UDI-Public: (01)00763000179632(17)211214
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/06/2019

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 Expiration Date: 12/14/2021
• Device Model Number: MMT-1755KR
• Device Catalogue Number: MMT-1755KR
• Device Lot Number: HG31GAB
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2019
• Initial Report FDA Received Date: 05/06/2019
• 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-UNK-RSVR, UNOMED UNK
• Outcome Attributed to Adverse Event: Other
• Patient Age: 65 YR
• Patient Weight: 68