MAUDE Adverse Event Report: MEDTRONIC MINIMED SENSOR ENLITE; OZO

Model Number MMT-7008A

Device Problems Bent (1059); Use of Device Problem (1670); Material Protrusion/Extrusion (2979)

Patient Problems Overdose (1988); Loss of consciousness (2418); Sweating (2444)

Event Date 03/25/2015

Event Type  malfunction  

Manufacturer Narrative

Reliability analysis: inspected (b)(4) opened/used sensors and performed a visual inspection and found (b)(4) sensors with the cannula retracted inside of the sensor base.They also found the cannula to be damaged (broken) and the broken part was missing.Among the (b)(4) remaining sensors, they found the needle hubs were separated from the sensor base.They were unable to confirm that the customer received the sensors in said condition due to the customer having returned opened/used sensors.Customer also had a complaint against the sen serter.

Event Description

The customer reported via phone call that she is on her third sensor and she cannot get the sensor on.Customer stated that the needle was bent.Customer's blood glucose was 123 mg/dl.Customer had the wrong serter and will be sent an enlite serter.Customer was advised that the sensors will be replaced.Customer stated that the paramedics had to be called because her father's the pump gave him over 150 units.Customer stated that her mother called 911 and her dad was on chemotherapy.Customer stated that her dad's pump was not indented but it was sticking out.Customer's mother woke up to find him unconscious and soaked.Customer's brother also had a drive support cap that was sticking out and his insulin pump was replaced.

• 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: 5077859
• MDR Text Key: 26204780
• Report Number: 2032227-2015-42768
• 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: Other
• Report Date: 03/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2015
• 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: 06/04/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/04/2015
• 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: 45 YR
• Patient Weight: 66