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

Model Number	MMT-751PNAS
Medical Device Problem Codes	Device Difficult to Program or Calibrate (1496); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A complete analysis and testing of the insulin pump showed that it was functioning properly and passed all functional testing.After testing it was concluded that the device operated within specifications.Pump received with minor scratches on lcd display window noted.Pump received with intermittent button response due to flattened dome switch on esc and act button.J2 connector was inspected and found was unlocked on lcd board.Pump passed displacement test and self test.
Event or Problem Description
Customer reported via phone call that buttons were worn and act or escape button has to push three time to respond.Customer¿s blood glucose was unknown.Customer stated that insulin pump¿s screen was lightly scratched and insulin pump was working fine.Insulin pump will be returned for analysis.
Additional Manufacturer Narrative
Insulin pump received with minor scratches on lcd display window noted.Insulin pump received with intermittent button response due to flattened dome switch on esc and act button.Connector was inspected and found was unlocked on lcd board.Pump passed displacement test and self test.(b)(4).

• Brand Name: 530G INSULIN PUMP MMT-751PNAS
• 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: 8814749
• Report Number: 2032227-2019-33887
• Device Sequence Number: 2348465
• Product Code: OZO
• UDI-Device Identifier: 00643169507357
• UDI-Public: (01)00643169507357
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 08/28/2019

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-751PNAS
• Device Catalogue Number: MMT-751PNAS
• Device Lot Number: A3751PNASJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2018
• Initial Date Received by Manufacturer: 02/25/2019
• Supplement Date Received by Manufacturer: 08/20/2019
• Initial Report FDA Received Date: 07/23/2019
• Supplement Report FDA Received Date: 08/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Weight: 180