MAUDE Adverse Event Report: MEDTRONIC MINIMED SENSOR ENLITE MMT-7008A; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number MMT-7008A

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Displays Incorrect Message (2591)

Patient Problems Hyperglycemia (1905); Rash (2033); Skin Irritation (2076)

Event Date 01/14/2018

Event Type  malfunction  

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

Customer reported via phone call for high blood glucose and sensor had inaccurate readings that triggered threshold suspend alarm.The customer¿s blood glucose was 600 mg/dl and the sensor glucose was 40 mg/dl at the time of the incident.Customer treated high blood glucose with insulin pump and shot.Customer reported that sensor glucose and blood glucose difference is not within acceptable range.The customer was informed that their blood glucose and sensor glucose levels were not in acceptable range.Customer reported that insulin delivery was suspended due to sensor glucose values.Sensor glucose value that triggered the suspend event: 60 mg/dl.Threshold/low suspend limit in sensor settings: 60 mg/dl.The sensor and insulin pump will not be returned for analysis.

• Brand Name: SENSOR ENLITE MMT-7008A
• 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: 7444115
• MDR Text Key: 106022894
• Report Number: 2032227-2018-02650
• 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: 04/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-7008A
• Device Catalogue Number: MMT-7008A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/02/2018
• Is the Device Single Use?: Yes
• 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: 28 YR
• Patient Weight: 135