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

Model Number MMT-7008B

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem Skin Irritation (2076)

Event Date 05/17/2017

Event Type  malfunction  

Manufacturer Narrative

Inspected 1 opened/used sensor and performed continuity resistance test and sensor failed test.Found cannula bent unable to confirm customer received sensor in said condition due to customer returned opened/used.

Event Description

The customer reported via phone call that they had sensor reading discrepancies and the insulin pump went into threshold suspend.The customer stated that the sensor was reading 58, but blood glucose value was 168 mg/dl.The customer was advised about insertion and calibration best practices.The sensor was removed and found the cannula was bent.The sensor was returned for analysis.

• Brand Name: SENSOR ENLITE MMT-7008B
• 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: 7597157
• MDR Text Key: 111317394
• Report Number: 2032227-2018-05427
• 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: 06/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-7008B
• Device Catalogue Number: MMT-7008B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/18/2017
• 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 Age: 62 YR
• Patient Weight: 177