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

Model Number	MMT-7020B
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Hyperglycemia (1905); Foreign Body In Patient (2687)
Date of Event	08/03/2018
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.The device will be returned for analysis and further information will follow once the analysis has been completed.No conclusion can be drawn at this time.
Event or Problem Description
Customer reported via phone call that they experienced high blood glucose.The customer blood glucose level was 522 mg/dl at the time of incident.Customer treated with insulin pump and manual injection.Troubleshooting was performed.The product will not be returned for analysis.
Additional Manufacturer Narrative
The information provided in the initial report was incorrect.The correct information has been included with this report.(b)(4).
Event or Problem Description
Adverse event has been updated to serious injury from malfunction.
Additional Manufacturer Narrative
Inspected 1 opened or used sensor and found cannula bent at sensor base.Unable to confirm customer received sensor in said condition due to customer returned opened or used.Customer did not return insertion needle.

• Brand Name: SENSOR MMT-7020B ENLITE3 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
• MDR Report Key: 7827282
• Report Number: 2032227-2018-20411
• Device Sequence Number: 1287532
• Product Code: OZP
• UDI-Device Identifier: 00763000017569
• UDI-Public: (01)00763000017569(17)190222(10)HG2C5RVH07
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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,Followup
• Report Date (Section B): 02/10/2020

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 Expiration Date: 02/22/2019
• Device Model Number: MMT-7020B
• Device Catalogue Number: MMT-7020B
• Device Lot Number: HG2C5RVH07
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2019
• Initial Date Received by Manufacturer: 08/03/2018
• Supplement Date Received by Manufacturer: 12/18/2018; 02/07/2020
• Initial Report FDA Received Date: 08/29/2018
• Supplement Report FDA Received Date: 12/20/2018; 02/10/2020
• 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: UNOMEDICAL INFUSION SETFRN RESERVOIR
• Outcome Attributed to Adverse Event: Other
• Patient Age: 56 YR
• Patient Weight: 71