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	Mechanical Problem (1384); Device Difficult to Program or Calibrate (1496)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 insulin pump received motor error alarm and button had hard to press.Customer¿s blood glucose level was unknown.The device will not be returned for analysis.
Additional Manufacturer Narrative
Device received with intermittent button response due to flattened act button dome switch (creased).No button error alarm during testing.No unlocked lcd keypad connector.Device passed the displacement test, rewind, basic occlusion, occlusion, prime or a33 and excessive no delivery test.No excessive no delivery or occlusion alarm noted.No motor error alarm noted.Motor passed motor test.Device passed self test.
Additional Manufacturer Narrative
Button response functioned properly.No button error alarm during testing.No unlocked lcd keypad connector.Device passed the displacement test, rewind, basic occlusion, occlusion, prime or a33 and excessive no delivery test.No excessive no delivery or occlusion alarm noted.No motor error alarm noted.Motor passed motor test.Device passed 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: 8661808
• Report Number: 2032227-2019-10342
• Device Sequence Number: 291324
• Product Code: OZO
• UDI-Device Identifier: 00643169507357
• UDI-Public: (01)00643169507357
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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,Followup
• Report Date (Section B): 05/18/2020

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-751PNAS
• Device Catalogue Number: MMT-751PNAS
• Device Lot Number: A3751PNASJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2019
• Initial Date Received by Manufacturer: 05/28/2019
• Supplement Date Received by Manufacturer: 02/11/2020; 05/15/2020
• Initial Report FDA Received Date: 06/03/2019
• Supplement Report FDA Received Date: 02/17/2020; 05/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 33 YR