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

Model Number	MMT-751RNAB
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	05/17/2017
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 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 he believes that his infusion sets were not giving him insulin.He said that he got a no delivery alarm.He changed out everything and received another no delivery and could not push insulin through with the plunger.Customer's blood glucose was 574 mg/dl.During troubleshooting, customer disconnected and reconnected infusion set and reservoir and pushed insulin with plunger; insulin did exit.Customer was advised that insulin pump was working as designed.After troubleshooting, advised him that he was not supposed to reattach the transfer guard to the reservoir after detachment.He stated that he did so in order to put more insulin in the reservoir.Now the cap is leaking insulin.Customer declined high blood glucose troubleshooting.He treated with shots.The product will be returned for analysis.

• Brand Name: 530G INSULIN PUMP MMT-751RNAB
• 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: 6638823
• Report Number: 3004209178-2017-55011
• Device Sequence Number: 19063888
• Product Code: OZO
• UDI-Device Identifier: 00643169507968
• UDI-Public: (01)00643169507968
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 06/13/2017

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-751RNAB
• Device Catalogue Number: MMT-751RNAB
• Device Lot Number: A3751RNABJ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2017
• Initial Report FDA Received Date: 06/13/2017
• 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: 65 YR
• Patient Weight: 204