MAUDE Adverse Event Report: MEDTRONIC MINIMED SENSOR MMT-7020B ENLITE3 US; ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL

Model Number	MMT-7020B
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	04/14/2018
Type of Reportable Event	Malfunction
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.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 low blood glucose.The blood glucose level was 35 mg/dl and then it was between 44 mg/dl and 52 mg/dl.Customer stated that they had blood glucose ranging from 110 mg/dl to 115 mg/dl.After few days the blood glucose was 134 mg/dl, 148 mg/dl and 187 mg/dl.Customer treated with juice and sometimes sugar for low blood glucose.Customer also reported getting alert for cannot find sensor signal and sensor updating.Troubleshooting was declined for low blood glucose.No product will return for analysis.
Additional Manufacturer Narrative
Inspected 1 opened/used sensor and performed visual inspection and found contact pad to be damaged (wrinkled).Unable to confirm customer received sensor in said condition due to customer returned opened/used.

• Brand Name: SENSOR MMT-7020B ENLITE3 US
• Common Device Name: ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL
• Manufacturer (Section D): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• MDR Report Key: 7517073
• Report Number: 2032227-2018-03297
• Device Sequence Number: 13766708
• Product Code: OZP
• UDI-Device Identifier: 00643169704060
• UDI-Public: (01)00643169704060(017)20190228
• 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,Followup
• Report Date (Section B): 04/10/2019

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: 02/28/2019
• Device Model Number: MMT-7020B
• Device Catalogue Number: MMT-7020B
• Device Lot Number: B288
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2019
• Initial Date Received by Manufacturer: 04/15/2018
• Supplement Date Received by Manufacturer: 04/04/2019
• Initial Report FDA Received Date: 05/15/2018
• Supplement Report FDA Received Date: 04/10/2019
• 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: 63 YR
• Patient Weight: 135