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	Display or Visual Feedback Problem (1184); Moisture or Humidity Problem (2986); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/18/2019
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.The device will be returned for analysis and further information will follow once the analysis has been completed.No conclusion can be drawn at this time.
Event or Problem Description
The customer reported via phone call that the screen got dull and can no longer see the screen.The customer¿s blood glucose level was unknown.There was a hairline crack on the bottom of the screen and there was condensation of water inside the screen.The customer reported that the light got dimmed and screen got to a point that it was very hard to read until it screen got dark.The customer was not able to perform self test.The customer was advised to discontinue use of the insulin pump and to revert to the back-up plan.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
Device received with blank display due to moisture damaged electronic assembly.Also moisture damage motor and vibrator during visual inspection.Unable to perform operating current test, a21 error test, displacement test or verify missing segment or display anomaly due to blank display.Device had minor scratched lcd window, no cracked lcd window noted.

• 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: 8948558
• Report Number: 2032227-2019-55325
• Device Sequence Number: 2472059
• Product Code: OZO
• UDI-Device Identifier: 00643169507357
• UDI-Public: (01)00643169507357
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 09/25/2019

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: 09/12/2019
• Initial Date Received by Manufacturer: 08/22/2019
• Supplement Date Received by Manufacturer: 09/18/2019
• Initial Report FDA Received Date: 08/30/2019
• Supplement Report FDA Received Date: 09/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 200