MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. KIT MMT-1755K PUMP 630G 3ML BK MG; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number	MMT-1755K
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	11/02/2016
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 they experienced low blood glucose level.Customer's blood glucose value was 61 mg/dl at the time of the incident then it was 40 mg/dl, blood glucose was 75 mg/dl, recent blood glucose was 200 mg/dl.The customer was assisted with troubleshooting and declined for low blood glucose.The customer was treated with 3 bottles of glucose syrup.Customer will not return device for analysis.

• Brand Name: KIT MMT-1755K PUMP 630G 3ML BK MG
• 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: 7594685
• Report Number: 3004209178-2018-80292
• Device Sequence Number: 18864687
• Product Code: OZO
• UDI-Device Identifier: 00643169752726
• UDI-Public: (01)00643169752726(017)20170303
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 06/12/2018

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 Expiration Date: 03/03/2017
• Device Model Number: MMT-1755K
• Device Catalogue Number: MMT-1755K
• Device Lot Number: HG1AEDB
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2016
• Initial Report FDA Received Date: 06/12/2018
• 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: 51 YR
• Patient Weight: 59