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

Model Number MMT-7008A

Device Problems Under-Sensing (1661); Low Readings (2460)

Patient Problem Hyperglycemia (1905)

Event Date 11/29/2017

Event Type  Injury  

Manufacturer Narrative

Inspected 1 opened/used sensor and performed continuity resistance test and sensor passed per specifications.Performed bicarbonate buffer test sensor passed per specifications.

Event Description

The customer reported via phone call the sensor had inaccurate readings that triggered threshold suspend alarm and had experienced high blood glucose level of 420 mg/dl.The customer¿s blood glucose was 255 mg/dl and the sensor glucose was 40 mg/dl at the time of the incident.Customer current blood glucose 184 mg/dl sensor glucose 55 mg/dl thresh is 60 mg/dl.Customer declined to troubleshoot for the high blood sugar troubleshoot was performed and the customer stated that insulin delivery was suspended which caused high blood glucose.The customer was informed that their blood glucose and sensor glucose levels were not in acceptable range.The sensor will 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 ; 8185464805
• MDR Report Key: 7681978
• MDR Text Key: 113783474
• Report Number: 2032227-2018-08157
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 01/29/2018
• Date Manufacturer Received: 11/30/2017
• 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 Outcome(s): Other
• Patient Age: 44 YR
• Patient Weight: 160