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

Model Number	MMT-751PNAP
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Obstruction of Flow (2423); Moisture or Humidity Problem (2986); Power Problem (3010); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Insulin ump received with blank display due to moisture damage at electronic assembly.Also, moisture damage motor during visual inspection.Unable to perform operating currents, self test, a21 error test, rewind test, basic occlusion test, occlusion test, prime/a33 test, excessive no delivery test and displacement test or verify battery out limit alarm, no excessive no delivery/occlusion alarm, missing segment/partial display and failed battery test due to blank display.Pump received with cracked case at the display window corners and cracked lcd window.(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
The customer reported via phone call that the insulin pump screen was foggy and had rainbow effect.The customer's blood glucose value was unknown at the time of the incident.The customer stated that insulin pump had unexplained no delivery alarms, battery life was diminished.The insulin pump will not be returned for analysis.

• Brand Name: 530G INSULIN PUMP MMT-751PNAP
• 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: 9265069
• Report Number: 2032227-2019-112040
• Device Sequence Number: 16606761
• Product Code: OZO
• UDI-Device Identifier: 00643169507340
• UDI-Public: (01)00643169507340
• 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
• Report Date (Section B): 11/01/2019

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-751PNAP
• Device Catalogue Number: MMT-751PNAP
• Device Lot Number: A3751PNAPJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2019
• Initial Report FDA Received Date: 11/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR