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

Model Number	MMT-551RNAS
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	06/02/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This mdr related to the puerto rico manufacturing site has been assigned a medwatch number from the medtronic minimed northridge site, per variance 5.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 to have experienced high blood glucose of 400 mg/dl.There are no symptoms related to high blood glucose were observed.Customer treated with manual injection and declined troubleshooting for high blood glucose.Customer also mentioned to have received lost sensor alert and performed and completed troubleshooting.Customer was assisted with finding lost sensor.Advised customer to call back if issue recurs.No product is expected to return for analysis.

• 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: 6673387
• Report Number: 2032227-2017-24228
• Device Sequence Number: 57347
• Product Code: OZO
• UDI-Device Identifier: 00643169507951
• UDI-Public: (01)00643169507951
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 06/28/2017

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-551RNAS
• Device Catalogue Number: MMT-551RNAS
• Device Lot Number: A3551RNASJ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2017
• Initial Report FDA Received Date: 06/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 125