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

Model Number	MMT-551RNAS
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	06/25/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 and reservoir lip ring.Customer's blood glucose value was 400 mg/dl at the time of the incident.The customer was assisted with troubleshooting and declined for high blood glucose.Customer will return device for analysis.
Additional Manufacturer Narrative
Device received with reservoir tube lip completely broken off noted.Unable to perform displacement test due to reservoir lip broken off.The test reservoir does not stay locked in place due to reservoir tube lip broken off.The information provided in the section of concomitant product with the initial report was incorrect.The correct information has been included with this report.

• Brand Name: 530G INSULIN PUMP MMT-551RNAS
• 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: 7724220
• Report Number: 3004209178-2018-96090
• Device Sequence Number: 658525
• Product Code: OZO
• UDI-Device Identifier: 00643169507951
• UDI-Public: (01)00643169507951
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 09/28/2018

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-551RNAS
• Device Catalogue Number: MMT-551RNAS
• Device Lot Number: A3551RNASJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2018
• Initial Date Received by Manufacturer: 06/26/2018
• Supplement Date Received by Manufacturer: 09/05/2018
• Initial Report FDA Received Date: 07/26/2018
• Supplement Report FDA Received Date: 09/28/2018
• 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: Other
• Patient Age: 74 YR
• Patient Weight: 192