MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 670G INSULIN PUMP MMT-1780KP; ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL

Model Number	MMT-1780KP
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	04/30/2020
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
The customer¿s family member reported via phone call that customer was hospitalized due to low blood glucose on (b)(6) 2020 with blood glucose of 40 mg/dl.The customer was treated with glucose tablets.The customer was reported that insulin pump was not on auto mode.Customer using insulin pump within 48 hours of low blood glucose of event.The insulin pump will not be returned for analysis.

• Brand Name: 670G INSULIN PUMP MMT-1780KP
• Common Device Name: ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386; * 00777-3869
• MDR Report Key: 10027581
• Report Number: 2032227-2020-113706
• Device Sequence Number: 3407584
• Product Code: OZP
• UDI-Device Identifier: 00763000173043
• UDI-Public: (01)00763000173043
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/05/2020

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-1780KP
• Device Catalogue Number: MMT-1780KP
• Device Lot Number: HG3JYPK
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2020
• Initial Report FDA Received Date: 05/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FRN-MMT-332-RSVR, UNOMED INF SET,OZP-MMT-7020-SNSR
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 47 YR