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

Model Number	MMT-751NAP
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Obstruction of Flow (2423); Material Integrity Problem (2978); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Unit was received with normal operating currents.Rewind test, basic occlusion test, occlusion test, prime/a33 test, excessive no delivery test and displacement test.No excessive no delivery/occlusion alarm noted.Pump failed self test.During back light check, there was a portion of the el panel that was not lit due to damaged el panel.Pump received with stripped battery cap coin slot(p), cracked battery tube threads and cracked reservoir tube lip.The test infusion set and reservoir does lock into place.(b)(4).
Event or Problem Description
Information received by medtronic indicated that the insulin pump had unexplained no delivery alarms, battery cap was stripped and worn, backlight was dimmer and hairline fracture near the screen.No harm requiring medical intervention was reported.The insulin pump was be returned for analysis.

• Brand Name: 530G INSULIN PUMP MMT-751NAP
• 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: 10738528
• Report Number: 2032227-2020-196388
• Device Sequence Number: 3457405
• Product Code: OZO
• UDI-Device Identifier: 00643169503700
• UDI-Public: (01)00643169503700
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 10/26/2020

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 Model Number: MMT-751NAP
• Device Catalogue Number: MMT-751NAP
• Device Lot Number: A4751NAPJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2020
• Initial Report FDA Received Date: 10/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 49 YR