MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SENSOR MMT-7020A ENLITE3 5PK US; ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL

Model Number	MMT-7020A
Medical Device Problem Codes	Break (1069); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Hyperglycemia (1905); Foreign Body In Patient (2687)
Date of Event	02/18/2020
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.(b)(4).
Event or Problem Description
The customer reported via phone call that they were hospitalized for high blood glucose and sensor stuck inside body on (b)(6) 2020.Blood glucose reading was 507 mg/dl.Customer was using auto mode.Customer was treated with manual injection and fluids in the emergency room.Customer reported that they did receive medical treatment as a result of the sensor fracturing while still in the body.Troubleshooting was declined for high blood glucose.The insulin pump and sensor will not be returned for analysis.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employees caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
The customer reported via phone call that they were visited emergency room for high blood glucose and sensor stuck inside body on february 18,2020.Blood glucose reading was 507 mg/dl.Customer was using auto mode.Customer was treated with manual injection and fluids in the emergency room.Customer reported that they did receive medical treatment as a result of the sensor fracturing while still in the body.Troubleshooting was declined for high blood glucose.The insulin pump and sensor will not be returned for analysis.

• Brand Name: SENSOR MMT-7020A ENLITE3 5PK US
• 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
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386
• Manufacturer Contact: gerwin de graaff ; ceiba norte ind. park #50 road; juncos 00777--386 ; 8185464805
• MDR Report Key: 9892540
• Report Number: 3004209178-2020-91295
• Device Sequence Number: 2050761
• Product Code: OZP
• UDI-Device Identifier: 20763000118864
• UDI-Public: (01)20763000118864(17)190601(10)HG2KTLS
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 06/30/2024

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: 06/01/2019
• Device Model Number: MMT-7020A
• Device Catalogue Number: MMT-7020A
• Device Lot Number: HG2KTLS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2020
• Supplement Date Received by Manufacturer: 06/20/2024
• Initial Report FDA Received Date: 03/28/2020
• Supplement Report FDA Received Date: 07/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FRN-MMT-332-RSVR,UNOMED-INF SET
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Weight: 180 KG