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

Model Number MMT-7008B

Device Problems Calibration Error (1078); Device Displays Incorrect Message (2591)

Patient Problem Hyperglycemia (1905)

Event Date 05/07/2017

Event Type  Injury  

Manufacturer Narrative

The sensor underwent the continuity resistance test and failed per specifications.The sensor cannula was also bent.Unable to confirm if customer received sensor in said condition due to customer returning an opened/used product.

Event Description

The customer reported via phone call that they had calibration errors, a change sensor alarm, and high blood glucose.The blood glucose at the time of the incident was 560 mg/dl.The customer declined troubleshooting.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 ; 8185464805
• MDR Report Key: 7662428
• MDR Text Key: 113152323
• Report Number: 2032227-2018-07861
• 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: Other
• Type of Report: Initial
• Report Date: 07/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 06/05/2017
• Date Manufacturer Received: 05/08/2017
• 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: 63 YR
• Patient Weight: 250