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

Model Number	MMT-551NAP
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/19/2017
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.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 they had a damage on the insulin pump.The customer's blood glucose level was unknown.The customer stated that they had damage to reservoir compartment and customer also stated that the black o-ring was broken off.The customer stated that the reservoir was unable to lock in place when inserted into pump.The customer was advised to discontinue use of the insulin pump and to revert to the back-up plan per health care professional¿s recommendation.The customer was advised that the pump needs to be replaced.The insulin pump will not be returned for analysis.

• Brand Name: 530G INSULIN PUMP MMT-551NAP
• 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: 7155747
• Report Number: 2032227-2017-78527
• Device Sequence Number: 19090618
• Product Code: OZO
• UDI-Device Identifier: 00643169736047
• UDI-Public: (01)00643169736047
• 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
• Report Date (Section B): 12/29/2017

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-551NAP
• Device Catalogue Number: MMT-551NAP
• Device Lot Number: A6551NAPJ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2017
• Initial Report FDA Received Date: 12/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Weight: 190