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

Model Number	MMT-751PNAB
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/01/2017
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 insulin pump had an lcd screen which has blue and black clouds on the screen.The customer¿s blood glucose level was unknown.Customer states the lcd screen has a blare making it hard to read.The customer was assisted with troubleshooting and customer can read the screen but does have some issues when it starts to blur.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
The device displayed properly and no display anomaly or bleeding was noted.The device had minor scratched lcd window, cracked lcd window, cracked battery tube threads, cracked reservoir tube lip, cracked case at display window corners, stained address label, serial number label and stained end cap sticker.

• Brand Name: 530G INSULIN PUMP MMT-751PNAB
• 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: 6847395
• Report Number: 2032227-2017-45279
• Device Sequence Number: 10790142
• Product Code: OZO
• UDI-Device Identifier: 00643169507319
• UDI-Public: (01)00643169507319
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2018

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-751PNAB
• Device Catalogue Number: MMT-751PNAB
• Device Lot Number: A3751PNABJ
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/30/2017
• Supplement Date Received by Manufacturer: 12/22/2017
• Initial Report FDA Received Date: 09/06/2017
• Supplement Report FDA Received Date: 01/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Weight: 133