MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP MMT-551PNAB; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number	MMT-551PNAB
Medical Device Problem Codes	Device Difficult to Program or Calibrate (1496); Battery Problem (2885)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/04/2019
Type of Reportable Event	Malfunction
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 the act buttons had to be pressed hard and was not doing what they are supposed to be doing and insulin pump frequently squirts insulin when priming.Customer's blood glucose level was unknown.The customer was declined to troubleshoot.The device will not be returned for analysis.
Additional Manufacturer Narrative
Device received with all buttons responding properly.No damage on keypad assembly.No unlocked lcd keypad connector.Device received with normal operating current.Device passed self test.Device passed off no power test.No unexpected low battery alarm anomalies noted.This mdr related to the (b)(4) manufacturing site has been assigned a medwatch number from the medtronic minimed (b)(4), per variance 5.

• Brand Name: 530G INSULIN PUMP MMT-551PNAB
• 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: 8410919
• Report Number: 3004209178-2019-65987
• Device Sequence Number: 16593328
• Product Code: OZO
• UDI-Device Identifier: 00643169507265
• UDI-Public: (01)00643169507265
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 12/17/2019

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-551PNAB
• Device Catalogue Number: MMT-551PNAB
• Device Lot Number: A3551PNABJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2019
• Initial Date Received by Manufacturer: 03/05/2019
• Supplement Date Received by Manufacturer: 12/16/2019
• Initial Report FDA Received Date: 03/12/2019
• Supplement Report FDA Received Date: 12/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 162