MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP MMT-551RNAS; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number	MMT-551RNAS
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	09/19/2017
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
Customer reported via phone call that they received compromised force sensor system alarm.Customer said that the blood glucose level was over 200mg/dl and was high for her and was not able to treat it.Customer was unable to troubleshoot for high blood glucose levels.Customer was advised to revert to back up plan per healthcare professional¿s instructions.Customer stated that the drive support cap appeared normal.The insulin pump will be returned for analysis and a replacement pump will be sent.
Additional Manufacturer Narrative
Insulin pump passed the displacement test but compromised force sensor system alarm during the basic occlusion test due to loose/protruded drive support disk.Unable to perform the occlusion, prime/compromised force sensor system and excessive no delivery test due to compromised force sensor system alarm.Insulin pump received with cracked case at the display window corner, cracked reservoir tube lip, minor scratched lcd window, stained end cap sticker, stained address/serial number label, cracked belt clip slot, cracked case reservoir tube window corner and cracked battery tube threads.

• Brand Name: 530G INSULIN PUMP MMT-551RNAS
• 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: 6895796
• Report Number: 2032227-2017-53097
• Device Sequence Number: 13794234
• Product Code: OZO
• UDI-Device Identifier: 00643169507951
• UDI-Public: (01)00643169507951
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 03/05/2018

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-551RNAS
• Device Catalogue Number: MMT-551RNAS
• Device Lot Number: A3551RNASJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2017
• Initial Date Received by Manufacturer: 09/19/2017
• Supplement Date Received by Manufacturer: 02/20/2018
• Initial Report FDA Received Date: 09/26/2017
• Supplement Report FDA Received Date: 03/05/2018
• 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: 115