MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 630G INSULIN PUMP MMT-1715KL 630G; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number	MMT-1715KL
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	06/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Adjusted the audio options audio volume 1-5 and each setting functioned properly.No unexpected audio or vibration anomalies noted.Unit passed displacement test, self test and rewind.However, loud motor noted during rewind.Problem isolated to motor.
Event or Problem Description
Information received by medtronic indicated that the insulin pump did not alarm her last night when she got the low battery alarm and the rewinding was too loud.Customer stated they saw missing segments during the self test.Customer stated the self test passed.No harm requiring medical intervention was reported.The insulin pump will be returned for analysis.

• Brand Name: 630G INSULIN PUMP MMT-1715KL 630G
• 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; * 00777-3869
• MDR Report Key: 10412395
• Report Number: 2032227-2020-163647
• Device Sequence Number: 12303608
• Product Code: OZO
• UDI-Device Identifier: 00763000316655
• UDI-Public: (01)00763000316655(17)230225
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 08/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/25/2023
• Device Model Number: MMT-1715KL
• Device Catalogue Number: MMT-1715KL
• Device Lot Number: HG44SE4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2020
• Initial Report FDA Received Date: 08/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 35 YR
• Patient Weight: 55