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

Model Number	MMT-7020A
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	05/05/2018
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.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
The customer reported via phone call that they received a medical intervention on (b)(6) 2018 for a low blood glucose of 21 mg/dl despite a sensor glucose of 122 mg/dl.Prior to the medical treatment, the customer was in bed and had a seizure due to the hypoglycemia.Ems arrived on scene and treated the customer with a glucagon shot.Troubleshooting was initiated for the sensor glucose inaccuracy but was inconclusive.The customer¿s blood glucose was 21 mg/dl and the sensor glucose was 122 mg/dl at the time of the incident.Customer was also reporting some sensors that were approximately 100 points off from the blood glucose.It is unknown if the auto mode feature was active during the hypoglycemic incident.The insulin pump is expected to return for analysis.The sensor is also expected to return for analysis.

• Brand Name: SENSOR MMT-7020A ENLITE3 5PK 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: 7928951
• Report Number: 2032227-2018-36275
• Device Sequence Number: 13937118
• Product Code: OZP
• UDI-Device Identifier: 20643169704057
• UDI-Public: (01)20643169704057(17)190413(10)D138
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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
• Report Date (Section B): 10/02/2018

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: 04/13/2019
• Device Model Number: MMT-7020A
• Device Catalogue Number: MMT-7020A
• Device Lot Number: D138
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2018
• Initial Report FDA Received Date: 10/02/2018
• 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 RESERVOIRUNOMED. INF. SET
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 39 YR
• Patient Weight: 260