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	Moisture or Humidity Problem (2986); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Insulin pump received with broken reservoir tube lip noted.Pump passed displacement test.The test reservoir was able to lock in place.Pump was inspected and found moisture damage to electronic devices noted.(b)(4).
Event or Problem Description
Information received by medtronic indicated that customer accidentally placed insulin pump to the washer.Customer reported that insulin pump had fluid in the reservoir compartment.The insulin pump had small crack on the top of it.No harm requiring medical intervention was reported.The insulin pump was returned for analysis.
Additional Manufacturer Narrative
Device received with cracked lcd display window corners noted.The test reservoir was able to lock in place.Device passed displacement test.However device alarmed motor error during basic occlusion test due to corroded home switch noted.Device was inspected and found moisture damage to most electronic devices noted.

• 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
• MDR Report Key: 9773368
• Report Number: 3004209178-2020-78396
• Device Sequence Number: 2330908
• Product Code: OZO
• UDI-Device Identifier: 00643169404335
• UDI-Public: (01)00643169404335
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Followup
• Report Date (Section B): 04/02/2020

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: A3751NAPJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2020
• Initial Date Received by Manufacturer: 02/25/2020
• Supplement Date Received by Manufacturer: 03/25/2020
• Initial Report FDA Received Date: 03/02/2020
• Supplement Report FDA Received Date: 04/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Weight: 160