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

Model Number MMT-7008A

Device Problems Over-Sensing (1438); High Readings (2459); Device Displays Incorrect Message (2591)

Patient Problem Hyperglycemia (1905)

Event Date 06/01/2018

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 the sensor had inaccurate readings that triggered threshold suspend alarm.The customer¿s blood glucose was 60 mg/dl and the sensor glucose were 90 mg/dl at the time of the incident.Insulin delivery was suspended due to sensor glucose values.The customer was advised issue is most likely due to sensor not situated properly preventing the sensor from properly tracking changes in glucose.Customer was informed that their blood glucose and sensor glucose levels were not in acceptable range.Suspend on low limit in sensor settings is 80.Customer was experiencing high blood glucose reading of 410.Customer did not troubleshoot their high blood glucose reading.Products will not return for analysis.

• Brand Name: SENSOR ENLITE MMT-7008A
• Type of Device: ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386
• Manufacturer Contact: gerwin de graaff ; ceiba norte ind. park #50 road; juncos 00777--386
• MDR Report Key: 7653378
• MDR Text Key: 112838037
• Report Number: 3004209178-2018-86716
• Device Sequence Number: 0
• Product Code: OZO
• 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: 06/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/18/2018
• Device Model Number: MMT-7008A
• Device Catalogue Number: MMT-7008A
• Device Lot Number: HG2EJ1B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/01/2018
• 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: 71 YR