MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SENSOR ENLITE MMT-7008A; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number	MMT-7008A
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/20/2018
Type of Reportable Event	Malfunction
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
The customer reported via phone call the sensor had inaccurate readings that triggered threshold suspend alarm.The patient¿s blood glucose was 187 mg/dl and the sensor glucose was 40 mg/dl at the time of the incident.Difference between blood glucose and sensor glucose was 147 mg/dl.Insulin delivery was suspended due to sensor glucose values.Sensor glucose value that triggered the suspend event was unknown.Threshold/low suspend limit in sensor settings was 60 mg/dl.Customer was informed that their blood glucose and sensor glucose levels were not in acceptable range.The device is expected to be returned for analysis.
Additional Manufacturer Narrative
Inspected one opened and used sensor and performed continuity resistance test and sensor passed per specifications.Performed the sensor initialization test using a new lab transmitter with a paradigm pump, connected the sensor to the transmitter and placed it in 100 buffered test solution, confirmed the communication icon was displayed and that the transmitter was flashing while connected to the sensor.Sensor passed per specifications.Cannot perform buffered test solution test as the sensor is beyond its expiration/event date.

• Brand Name: SENSOR ENLITE MMT-7008A
• Common Device Name: ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386
• MDR Report Key: 7933126
• Report Number: 2032227-2018-37039
• Device Sequence Number: 16728855
• Product Code: OZO
• UDI-Device Identifier: 20643169646432
• UDI-Public: (01)20643169646432(17)171022(10)HG1TA2X
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/22/2017
• Device Model Number: MMT-7008A
• Device Catalogue Number: MMT-7008A
• Device Lot Number: HG1TA2X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2019
• Initial Date Received by Manufacturer: 09/20/2018
• Supplement Date Received by Manufacturer: 01/31/2020
• Initial Report FDA Received Date: 10/04/2018
• Supplement Report FDA Received Date: 02/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Weight: 86