MAUDE Adverse Event Report: MEDTRONIC MINIMED SENSOR ENLITE; OZO

Model Number MMT-7008A

Device Problem Device Contamination with Body Fluid (2317)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 03/11/2017

Event Type  malfunction  

Manufacturer Narrative

Reliability analysis inspected 1 opened/used partial enlite sensor and found sensor cannula retracted and broken inside sensor base.Missing broke part.Unable to confirmed customer received sensor in said condition due to customer returned opened/used.Unable to confirm insertion/needle anomalies due to customer did not return insertion needle.

Event Description

The customer reported via phone call that they experienced blood at site.The customer's blood glucose value was unknown.The customer stated that she put in a sensor and it started bleeding.The customer reported that they might have been on a low dose of aspirin.The product was returned for analysis.

• Brand Name: SENSOR ENLITE
• Type of Device: OZO
• Manufacturer (Section D): MEDTRONIC MINIMED; 18000 devonshire street; northridge CA 91325
• Manufacturer (Section G): MEDTRONIC MINIMED; 18000 devonshire street; northridge CA 91325 1219
• Manufacturer Contact: gerwin de graaff ; 18000 devonshire street; northridge, CA 91325-1219 ; 8185764805
• MDR Report Key: 6754777
• MDR Text Key: 81568666
• Report Number: 2032227-2017-99079
• Device Sequence Number: 1
• Product Code: OZO
• Combination Product (y/n): N
• PMA/PMN Number: 120010
• 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: 07/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2017
• 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: 03/31/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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: 60 YR
• Patient Weight: 65