MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. KIT MMT-1755K PUMP 630G 3ML BK MG; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number	MMT-1755K
Medical Device Problem Codes	Moisture or Humidity Problem (2986); Power Problem (3010)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/12/2019
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
It was reported that insulin pump had open book image on the pump screen.The blood glucose level was 150 mg/dl at the time of incident.Customer stated that there was no any alarm was displayed before the open book image was displayed on the screen.Customer stated that the insulin pump was exposed to moisture.The customer was advised to discontinue use of the insulin pump and to revert to the back-up plan.The insulin pump will not be returned for analysis.
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.

• Brand Name: KIT MMT-1755K PUMP 630G 3ML BK MG
• 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: 9532007
• Report Number: 2032227-2019-139577
• Device Sequence Number: 411843
• Product Code: OZO
• UDI-Device Identifier: 00643169752726
• UDI-Public: (01)00643169752726
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2020

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-1755K
• Device Catalogue Number: MMT-1755K
• Device Lot Number: HG1YZB1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/12/2019
• Supplement Date Received by Manufacturer: 01/21/2020
• Initial Report FDA Received Date: 12/30/2019
• Supplement Report FDA Received Date: 01/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1