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

Model Number MMT-XXX

Device Problems Break (1069); No Apparent Adverse Event (3189)

Patient Problems Needle Stick/Puncture (2462); Foreign Body In Patient (2687)

Event Date 01/29/2020

Event Type  Injury  

Manufacturer Narrative

Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.

Event Description

The customer¿s family member reported via phone call that there was only metal rod left on the sensor after removal.Customer¿s blood glucose level was 400 mg/dl, at the time of incidence.Customer reported that the sensor fractured and it was still in the body.Customer did not received any medical treatment as a result of sensor fractured in the body.The device will not be returned for analysis.

• Brand Name: SENSOR ENLITE
• 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: 9668943
• MDR Text Key: 177791212
• Report Number: 2032227-2020-100918
• Device Sequence Number: 1
• Product Code: OZO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 02/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-XXX
• Device Catalogue Number: MMT-XXX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/29/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: MDS-UNK-XMTR
• Patient Outcome(s): Other
• Patient Age: 16 YR
• Patient Weight: 130