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

Model Number	MMT-751RNAS
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	09/02/2017
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 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
Customer reported via phone call that they experienced high blood glucose 600 mg/dl which was treated with manual injection.Customer¿s blood glucose was 360 mg/dl at the time of call.Drive support cap was normal.Customer states that blood glucose was 172 mg/dl, 445 mg/dl, 600 mg/dl and on treating manual injection and it went to 549 mg/dl, 508 mg/dl, 302 mg/dl.Troubleshooting was performed.The customer did not find issues with the insulin pump.High pressure test passed.Customer advised to change entire set and treat as per hcp¿s instructions.Insulin pump will not be return for analysis.

• Brand Name: 530G INSULIN PUMP MMT-751RNAS
• 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: 7069148
• Report Number: 2032227-2017-69032
• Device Sequence Number: 11212227
• Product Code: OZO
• UDI-Device Identifier: 00643169508002
• UDI-Public: (01)00643169508002
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 11/29/2017

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-751RNAS
• Device Catalogue Number: MMT-751RNAS
• Device Lot Number: A3751RNASJ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2017
• Initial Report FDA Received Date: 11/29/2017
• 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: Other
• Patient Age: 88 YR
• Patient Weight: 203