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

Model Number MMT-7008A

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Bruise/Contusion (1754); Hyperglycemia (1905); No Consequences Or Impact To Patient (2199); Blood Loss (2597)

Event Date 08/14/2017

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.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 Description

Customer called to report issues with sensor glucose verses blood glucose differences.Customer stated that the insulin pump alarmed threshold suspend.Customer's blood glucose reading was 230 mg/dl, while the sensor glucose was 125 mg/dl.Insulin delivery was suspended due to sensor glucose values.Sensor glucose value that triggered the suspend event was 68 mg/dl.Customer stated that the threshold suspend alarm was set at 75 mg/dl.Therefore, sensor glucose and blood glucose difference was not within acceptable range.Troubleshooting was done.Product is expected to return.

Manufacturer Narrative

Inspected one opened/used partial sensor and performed continuity resistance test found sensor passed per specifications and 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 bts solution, confirmed the communication icon was displayed and that the transmitter was flashing while connected to the sensor.Unable to confirm insertion anomaly due to customer did not return insertion needle only sensor.The sensor functioned properly.Cannot performed bts test as the sensor is beyond its expiration date.

• 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: 6836432
• MDR Text Key: 84620249
• Report Number: 2032227-2017-43484
• 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,Followup
• Report Date: 05/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2017
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 50 YR
• Patient Weight: 300