MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP; INSULIN INFUSION PUMP / SENSOR AUGMENTED

Model Number MMT-523LNAL

Device Problems Break (1069); Detachment Of Device Component (1104); Crack (1135); Device Dislodged or Dislocated (2923)

Patient Problem Hyperglycemia (1905)

Event Date 05/09/2016

Event Type  malfunction  

Manufacturer Narrative

The insulin pump was received with reservoir tube lip completely broken off.The reservoir does not stay locked into place, the device was received with a cracked case at the display window corners and cracked case at the reservoir tube window corners.The insulin pump was received with missing o-ring reservoir tube and the device was received with minor scratches on the lcd window.

Event Description

Customer reported via phone call cosmetic damage on the insulin pump.Customer's blood glucose level was 312 mg/dl.Customer treated their blood glucose via bolus delivery.Troubleshooting for cosmetic damage was performed.Customer advised the top of the insulin pump where the reservoir is placed had come off.Customer advised the reservoir compartment had cracked and popped off.Customer was advised to discontinue use of the device and revert to a backup plan.Customer was advised that the device would be replaced and agreed to return the product for analysis.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
• Type of Device: INSULIN INFUSION PUMP / SENSOR AUGMENTED
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50; road 31 km 24.4; juncos PR 00777 3869
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50; road 31 km 24.4; juncos PR 00777 3869
• Manufacturer Contact: gerwin de graaff ; 18000 devonshire street; northridge, CA 91325-1219 ; 8185764805
• MDR Report Key: 5683415
• MDR Text Key: 46191903
• Report Number: 3004209178-2016-50852
• 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: 05/16/2016

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-523LNAL
• Device Catalogue Number: MMT-523LNAL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/13/2016
• Initial Date FDA Received: 05/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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: 34 YR
• Patient Weight: 61