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

Model Number	MMT-751NAP
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	12/15/2017
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 they experienced high blood glucose level of 310 mg/dl.The customer¿s current blood glucose was 139 mg/dl.The customer treated with manual injections.Customer was alleging possible pump under delivery.Troubleshooting was performed.The drive support cap appeared normal.The product will be returned for analysis.
Additional Manufacturer Narrative
Pump passed displacement test, rewind test, basic occlusion test, prime test, excessive no delivery test, occlusion test, self test and unexpected restart error test.No bolus anomaly noted during testing.Pump passed all operating currents tested within the specification range and passed off no power test.Pump passed the delivery accuracy test.Pump received with cracked reservoir tube lip, missing drive support sticker and minor scratches on display window noted.Drive support cap was inspected and no anomaly was noted.

• Brand Name: 530G INSULIN PUMP MMT-751NAP
• 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: 7152156
• Report Number: 2032227-2017-77887
• Device Sequence Number: 73107
• Product Code: OZO
• UDI-Device Identifier: 00643169736092
• UDI-Public: (01)00643169736092
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 05/18/2018

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-751NAP
• Device Catalogue Number: MMT-751NAP
• Device Lot Number: A6751NAPJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2018
• Initial Date Received by Manufacturer: 12/16/2017
• Supplement Date Received by Manufacturer: 05/07/2018
• Initial Report FDA Received Date: 12/28/2017
• Supplement Report FDA Received Date: 05/18/2018
• 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: 140