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

Model Number	MMT-751PNAH
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	07/11/2018
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 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 were hospitalized due to high blood glucose on (b)(6) 2018 with blood glucose of 639 mg/dl and then on (b)(6) 2018 with blood glucose of 520 mg/dl.The customer was treated by insulin and intravenous fluids.Troubleshooting was done for high blood glucose and under delivery.Customer was off the insulin pump since (b)(6) 2018.Customer states the drive support cap appears normal.The customer was wearing the insulin pump during the hospitalization.The insulin pump will not be returned for analysis.
Additional Manufacturer Narrative
The device received with all operating currents within specification and passed functional testing including the rewind, basic occlusion, occlusion, prime or compromised force sensor system, excessive no delivery, self test, unexpected restart error and displacement test.Pump passed the dat test at 0.08735 inches.The device received with cracked case at display window corners, display window, reservoir tube lip and battery tube threads.The device received with minor scratched display window and case.

• Brand Name: 530G INSULIN PUMP MMT-751PNAH
• 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: 7783161
• Report Number: 2032227-2018-13123
• Device Sequence Number: 1392157
• Product Code: OZO
• UDI-Device Identifier: 00643169507326
• UDI-Public: (01)00643169507326
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2018

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-751PNAH
• Device Catalogue Number: MMT-751PNAH
• Device Lot Number: A3751PNAHJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2018
• Initial Date Received by Manufacturer: 07/16/2018
• Supplement Date Received by Manufacturer: 09/14/2018
• Initial Report FDA Received Date: 08/14/2018
• Supplement Report FDA Received Date: 10/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 32 YR
• Patient Weight: 278