MAUDE Adverse Event Report: MEDTRONIC MINIMED PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP; INSULIN INFUSION PUMP / SENSOR AUGMENTED

Model Number MMT-723NAS

Device Problems Break (1069); Crack (1135); Device Dislodged or Dislocated (2923); Scratched Material (3020)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/20/2016

Event Type  malfunction  

Manufacturer Narrative

The insulin pump was received with cracked case at the display window corner, broken reservoir tube lip, minor scratched lcd window, missing reservoir tube o-ring and cracked battery tube threads.A test reservoir was installed and did not lock in place due to complete broken reservoir tube lip noted during testing.

Event Description

The customer reported via phone call that the o-ring popped out and would not stay in the reservoir compartment.The customer's blood glucose was unknown at the time of incident.The customer was advised that the insulin pump will need to be replaced.The customer was advised to disconnect from the insulin pump and revert to back-up plan.The insulin pump will be returned for analysis.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
• Type of Device: INSULIN INFUSION PUMP / SENSOR AUGMENTED
• 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: 5878994
• MDR Text Key: 52901517
• Report Number: 2032227-2016-15721
• Device Sequence Number: 1
• Product Code: OYC
• Combination Product (y/n): N
• PMA/PMN Number: P980022
• 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: 08/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-723NAS
• Device Catalogue Number: MMT-723NAS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/09/2016
• Initial Date FDA Received: 08/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2013
• 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
• Patient Age: 65 YR
• Patient Weight: 93