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	Incorrect, Inadequate or Imprecise Result or Readings (1535); Calibration Problem (2890)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Inspected one random opened/used sensor and found cannula retracted inside sensor base.Unable to confirm customer received sensor in said condition due to customer returned opened/used.Also found 2 of 4 opened/used sensors with insertion needle bent in sensor base.Unable to confirm customer received sensors in said condition due to customer returned opened/used.
Event or Problem Description
Customer reported via phone call that the sensor had inaccurate readings that triggered threshold suspend alarm.The customer¿s blood glucose was 140 mg/dl, 120 mg/dl and the sensor glucose was 40 mg/dl.The customer was assisted with troubleshooting.Insulin delivery was suspended due to sensor values.Customer states the sensor value that triggered the suspend on low or suspend before low event was 40 mg/dl.Suspend on low limit in sensor settings was not check.The customer was informed that their blood glucose and sensor glucose levels were not in acceptable range.The sensor was 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
• MDR Report Key: 8629969
• Report Number: 2032227-2019-04951
• Device Sequence Number: 19318229
• Product Code: OZP
• UDI-Device Identifier: 20763000118864
• UDI-Public: (01)20763000118864(17)190612(10)HG2LK2B
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 05/21/2019

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: 06/12/2019
• Device Model Number: MMT-7020A
• Device Catalogue Number: MMT-7020A
• Device Lot Number: HG2LK2B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2018
• Initial Report FDA Received Date: 05/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 15 YR
• Patient Weight: 115