MAUDE Adverse Event Report: MEDTRONIC MINIMED SENSOR ENLITE; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number MMT-XXX

Device Problems False Reading From Device Non-Compliance (1228); Device Displays Incorrect Message (2591)

Patient Problem Hyperglycemia (1905)

Event Date 05/07/2018

Event Type  Injury  

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.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.

Event Description

The customer reported via phone call that they were having issues with sensor calibration.Customer received a change sensor alert after a calibration not accepted.Customer declined to review sensor best practices (site selection, taping, calibration protocol) to improve accuracy.The customer¿s blood glucose level was 400 mg/dl when they woke up in the morning.Blood glucose was 223 mg/dl at the time of the call.Customer declined troubleshooting for high blood glucose.Customer was advised the sensor will be replaced.No product is expected to return.

• Brand Name: SENSOR ENLITE
• Type of Device: ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND
• Manufacturer (Section D): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• Manufacturer (Section G): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• Manufacturer Contact: gerwin de graaff ; 18000 devonshire st.; northridge, CA 91325-1219
• MDR Report Key: 7576413
• MDR Text Key: 110322749
• Report Number: 2032227-2018-04578
• Device Sequence Number: 1
• Product Code: OZO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-XXX
• Device Catalogue Number: MMT-XXX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/07/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 22 YR
• Patient Weight: 140