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	Hyperglycemia (1905)
Date of Event	07/16/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Currently it is unknown whether or not the device may have caused or contributed to the event.The device has been returned, but not yet evaluated.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 experienced high blood glucose level of 440 mg/dl.Customer declined troubleshooting for high blood glucose reading.Customer also reported power issue and failed battery test.Insulin pump will be returning for analysis.
Additional Manufacturer Narrative
Findings: unit power up properly after battery installation.No blank display noted.Unit was received with normal operating currents and no unexpected off no power, weak battery, bad battery, low battery, battery out limit and failed battery test alarms during testing.Unit passed self-test, unexpected alarm error test, rewind test, basic occlusion test, occlusion test, prime test, excessive no delivery test and displacement test.Unit had minor scratched lcd window, cracked battery tube threads and cracked reservoir tube lip.A complete analysis and testing of the insulin pump showed that it was functioning properly and passed all functional testing.After testing it was concluded that the device operated within specifications.

• 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: 6786867
• Report Number: 2032227-2017-36012
• Device Sequence Number: 139150
• Product Code: OZO
• UDI-Device Identifier: 00643169736047
• UDI-Public: (01)00643169736047
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 10/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2017
• Initial Date Received by Manufacturer: 07/16/2017
• Supplement Date Received by Manufacturer: 10/10/2017
• Initial Report FDA Received Date: 08/10/2017
• Supplement Report FDA Received Date: 10/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 150